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Purple Book
Database of Licensed Biological Products

The Purple Book database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products.

The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER).

Enter a product's proprietary (brand) name or the nonproprietary (proper) name to find biological products. As you type, a list of potential results will begin to appear below the search box based on what you are typing. Click on a product from the auto-populated results list below to view the results page. The results page for your selected product will include all biological products that share a core name (i.e., biosimilar, interchangeable, reference, and related biological products).

  • (Antivenin (Latrodectus mactans))
    BLA Number: 101062
    351(a)
  • (Antivenin (Latrodectus mactans))
    BLA Number: 101062
    351(a)
  • (Antivenin (Micrurus fulvius))
    BLA Number: 101099
    351(a)
  • A.P.L. (chorionic gonadotropin)
    BLA Number: 017055
    351(a)
  • A.P.L. (chorionic gonadotropin)
    BLA Number: 017055
    351(a)
  • A.P.L. (chorionic gonadotropin)
    BLA Number: 017055
    351(a)
  • Abecma (idecabtagene vicleucel)
    BLA Number: 125736
    351(a)
  • Abecma (idecabtagene vicleucel)
    BLA Number: 125736
    351(a)
  • Abrilada (adalimumab-afzb)
    BLA Number: 761118
    351(k) Interchangeable
  • Abrilada (adalimumab-afzb)
    BLA Number: 761118
    351(k) Interchangeable
  • Abrilada (adalimumab-afzb)
    BLA Number: 761118
    351(k) Interchangeable
  • Abrilada (adalimumab-afzb)
    BLA Number: 761118
    351(k) Interchangeable
  • Abrilada (adalimumab-afzb)
    BLA Number: 761118
    351(k) Interchangeable
  • Abrysvo (Respiratory Syncytial Virus Vaccine)
    BLA Number: 125769
    351(a)
  • Acam2000 (Smallpox (Vaccinia) Vaccine, Live)
    BLA Number: 125158
    351(a)
  • Accretropin (somatropin)
    BLA Number: 021538
    351(a)
  • Actemra (tocilizumab)
    BLA Number: 125276
    351(a)
  • Actemra (tocilizumab)
    BLA Number: 125276
    351(a)
  • Actemra (tocilizumab)
    BLA Number: 125276
    351(a)
  • Actemra (tocilizumab)
    BLA Number: 125472
    351(a)
  • Actemra (tocilizumab)
    BLA Number: 125472
    351(a)
  • Acthib,Omnihib (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))
    BLA Number: 103935
    351(a)
  • Acthrel (corticorelin ovine triflutate)
    BLA Number: 020162
    351(a)
  • Actimmune (interferon gamma-1b)
    BLA Number: 103836
    351(a)
  • Activase (alteplase)
    BLA Number: 103172
    351(a)
  • Activase (alteplase)
    BLA Number: 103172
    351(a)
  • Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
    BLA Number: 125111
    351(a)
  • Adagen (pegademase bovine)
    BLA Number: 019818
    351(a)
  • Adakveo (crizanlizumab-tmca)
    BLA Number: 761128
    351(a)
  • Adbry (tralokinumab-ldrm)
    BLA Number: 761180
    351(a)
  • Adbry (tralokinumab-ldrm)
    BLA Number: 761180
    351(a)
  • Adcetris (brentuximab vedotin)
    BLA Number: 125388
    351(a)
  • Adlyxin (lixisenatide)
    BLA Number: 208471
    351(a)
  • Adlyxin (lixisenatide)
    BLA Number: 208471
    351(a)
  • Admelog (insulin lispro)
    BLA Number: 209196
    351(a)
  • Admelog (insulin lispro)
    BLA Number: 209196
    351(a)
  • Admelog (insulin lispro)
    BLA Number: 209196
    351(a)
  • Adstiladrin (nadofaragene firadenovec-vncg)
    BLA Number: 125700
    351(a)
  • Aduhelm (aducanumab-avwa)
    BLA Number: 761178
    351(a)
  • Aduhelm (aducanumab-avwa)
    BLA Number: 761178
    351(a)
  • Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
    BLA Number: 125063
    351(a)
  • Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
    BLA Number: 125063
    351(a)
  • Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
    BLA Number: 125063
    351(a)
  • Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
    BLA Number: 125063
    351(a)
  • Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
    BLA Number: 125063
    351(a)
  • Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
    BLA Number: 125063
    351(a)
  • Advate (Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method)
    BLA Number: 125063
    351(a)
  • Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
    BLA Number: 125566
    351(a)
  • Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
    BLA Number: 125566
    351(a)
  • Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
    BLA Number: 125566
    351(a)
  • Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
    BLA Number: 125566
    351(a)
  • Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
    BLA Number: 125566
    351(a)
  • Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
    BLA Number: 125566
    351(a)
  • Adynovate (Antihemophilic Factor (Recombinant), PEGylated)
    BLA Number: 125566
    351(a)
  • ADZYNMA (ADAMTS13, recombinant-krhn)
    BLA Number: 125795
    351(a)
  • ADZYNMA (ADAMTS13, recombinant-krhn)
    BLA Number: 125795
    351(a)
  • Afluria, Afluria Quadrivalent (Influenza Vaccine)
    BLA Number: 125254
    351(a)
  • Afluria, Afluria Quadrivalent (Influenza Vaccine)
    BLA Number: 125254
    351(a)
  • Afluria, Afluria Quadrivalent (Influenza Vaccine)
    BLA Number: 125254
    351(a)
  • Afluria, Afluria Quadrivalent (Influenza Vaccine)
    BLA Number: 125254
    351(a)
  • Afluria, Afluria Quadrivalent (Influenza Vaccine)
    BLA Number: 125254
    351(a)
  • Afrezza (insulin human)
    BLA Number: 022472
    351(a)
  • Afrezza (insulin human)
    BLA Number: 022472
    351(a)
  • Afrezza (insulin human)
    BLA Number: 022472
    351(a)
  • Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
    BLA Number: 125591
    351(a)
  • Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
    BLA Number: 125591
    351(a)
  • Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
    BLA Number: 125591
    351(a)
  • Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
    BLA Number: 125591
    351(a)
  • Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
    BLA Number: 125591
    351(a)
  • Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
    BLA Number: 125591
    351(a)
  • Afstyla (Antihemophilic Factor (Recombinant), Single Chain)
    BLA Number: 125591
    351(a)
  • Agriflu (Influenza Virus Vaccine)
    BLA Number: 125297
    351(a)
  • Ahzantive (aflibercept-mrbb)
    BLA Number: 761378
    351(k) Biosimilar
  • Ahzantive (aflibercept-mrbb)
    BLA Number: 761378
    351(k) Biosimilar
  • Aimovig (erenumab-aooe)
    BLA Number: 761077
    351(a)
  • Aimovig (erenumab-aooe)
    BLA Number: 761077
    351(a)
  • Aimovig (erenumab-aooe)
    BLA Number: 761077
    351(a)
  • Aimovig (erenumab-aooe)
    BLA Number: 761077
    351(a)
  • Ajovy (fremanezumab-vfrm)
    BLA Number: 761089
    351(a)
  • Ajovy (fremanezumab-vfrm)
    BLA Number: 761089
    351(a)
  • Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
    BLA Number: 101138
    351(a)
  • Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
    BLA Number: 101138
    351(a)
  • Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
    BLA Number: 101138
    351(a)
  • Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
    BLA Number: 101138
    351(a)
  • Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
    BLA Number: 101138
    351(a)
  • Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
    BLA Number: 101138
    351(a)
  • Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
    BLA Number: 101138
    351(a)
  • Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5 (Albumin (Human))
    BLA Number: 101138
    351(a)
  • Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
    BLA Number: 103955
    351(a)
  • Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
    BLA Number: 103955
    351(a)
  • Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
    BLA Number: 103955
    351(a)
  • Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
    BLA Number: 103955
    351(a)
  • Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
    BLA Number: 103955
    351(a)
  • Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
    BLA Number: 103955
    351(a)
  • Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
    BLA Number: 103955
    351(a)
  • Albuminar, Albuminar-20, Albuminar-25, Albuminar-5 (Albumin (Human))
    BLA Number: 103955
    351(a)
  • Albuminex (Albumin (Human)-kjda)
    BLA Number: 125644
    351(a)
  • Albuminex (Albumin (Human)-kjda)
    BLA Number: 125644
    351(a)
  • Albuminex (Albumin (Human)-kjda)
    BLA Number: 125644
    351(a)
  • Albuminex (Albumin (Human)-kjda)
    BLA Number: 125644
    351(a)
  • Alburx (Albumin (Human))
    BLA Number: 102366
    351(a)
  • Alburx (Albumin (Human))
    BLA Number: 102366
    351(a)
  • Alburx (Albumin (Human))
    BLA Number: 102366
    351(a)
  • Alburx (Albumin (Human))
    BLA Number: 102366
    351(a)
  • Albutein (Albumin (Human))
    BLA Number: 102478
    351(a)
  • Albutein (Albumin (Human))
    BLA Number: 102478
    351(a)
  • Albutein (Albumin (Human))
    BLA Number: 102478
    351(a)
  • Albutein (Albumin (Human))
    BLA Number: 102478
    351(a)
  • Albutein (Albumin (Human))
    BLA Number: 102478
    351(a)
  • Albutein (Albumin (Human))
    BLA Number: 102478
    351(a)
  • Albutein (Albumin (Human))
    BLA Number: 102478
    351(a)
  • Albutein (Albumin (Human))
    BLA Number: 102478
    351(a)
  • Albutein (Albumin (Human))
    BLA Number: 102478
    351(a)
  • Aldurazyme (laronidase)
    BLA Number: 125058
    351(a)
  • Alferon N Injection (interferon alfa-n3 (human leukocyte derived))
    BLA Number: 103158
    351(a)
  • Alhemo (concizumab-mtci)
    BLA Number: 761315
    351(a)
  • Alhemo (concizumab-mtci)
    BLA Number: 761315
    351(a)
  • Alhemo (concizumab-mtci)
    BLA Number: 761315
    351(a)
  • Allocord (HPC, Cord Blood)
    BLA Number: 125413
    351(a)
  • Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human))
    BLA Number: 102475
    351(a)
  • Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human))
    BLA Number: 102475
    351(a)
  • Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human))
    BLA Number: 102475
    351(a)
  • Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human))
    BLA Number: 102475
    351(a)
  • Alphanate (Antihemophilic Factor/von Willebrand Factor Complex (Human))
    BLA Number: 102475
    351(a)
  • Alphanine, Alphanine Hp, Alphanine Sd (Coagulation Factor IX (Human))
    BLA Number: 103249
    351(a)
  • Alphanine, Alphanine Hp, Alphanine Sd (Coagulation Factor IX (Human))
    BLA Number: 103249
    351(a)
  • Alphanine, Alphanine Hp, Alphanine Sd (Coagulation Factor IX (Human))
    BLA Number: 103249
    351(a)
  • Alphanine, Alphanine Hp, Alphanine Sd (Coagulation Factor IX (Human))
    BLA Number: 103249
    351(a)
  • Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
    BLA Number: 125444
    351(a)
  • Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
    BLA Number: 125444
    351(a)
  • Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
    BLA Number: 125444
    351(a)
  • Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
    BLA Number: 125444
    351(a)
  • Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
    BLA Number: 125444
    351(a)
  • Alprolix (Coagulation Factor IX (Recombinant), Fc Fusion Protein)
    BLA Number: 125444
    351(a)
  • ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
    BLA Number: 125771
    351(a)
  • ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
    BLA Number: 125771
    351(a)
  • ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
    BLA Number: 125771
    351(a)
  • ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
    BLA Number: 125771
    351(a)
  • ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
    BLA Number: 125771
    351(a)
  • ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
    BLA Number: 125771
    351(a)
  • ALTUVIIIO (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl)
    BLA Number: 125771
    351(a)
  • Alyglo (immune globulin intravenous, human-stwk)
    BLA Number: 125743
    351(a)
  • Alymsys (bevacizumab-maly)
    BLA Number: 761231
    351(k) Biosimilar
  • Alymsys (bevacizumab-maly)
    BLA Number: 761231
    351(k) Biosimilar
  • Amevive (alefacept)
    BLA Number: 125036
    351(a)
  • Amevive (alefacept)
    BLA Number: 125036
    351(a)
  • Amjevita (adalimumab-atto)
    BLA Number: 761024
    351(k) Interchangeable
  • Amjevita (adalimumab-atto)
    BLA Number: 761024
    351(k) Interchangeable
  • Amjevita (adalimumab-atto)
    BLA Number: 761024
    351(k) Interchangeable
  • Amjevita (adalimumab-atto)
    BLA Number: 761024
    351(k) Interchangeable
  • Amjevita (adalimumab-atto)
    BLA Number: 761024
    351(k) Interchangeable
  • Amjevita (adalimumab-atto)
    BLA Number: 761024
    351(k) Interchangeable
  • Amjevita (adalimumab-atto)
    BLA Number: 761024
    351(k) Interchangeable
  • Amjevita (adalimumab-atto)
    BLA Number: 761024
    351(k) Interchangeable
  • Amjevita (adalimumab-atto)
    BLA Number: 761024
    351(k) Interchangeable
  • Amphadase (hyaluronidase)
    BLA Number: 021665
    351(a)
  • AMTAGVI (Lifileucel)
    BLA Number: 125773
    351(a)
  • Anascorp (Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection)
    BLA Number: 125335
    351(a)
  • Anavip (Crotalidae Immune F(ab')2 (Equine))
    BLA Number: 125488
    351(a)
  • Andembry (garadacimab-gxii)
    BLA Number: 761367
    351(a)
  • Andembry (garadacimab-gxii)
    BLA Number: 761367
    351(a)
  • Andexxa (Coagulation Factor Xa (Recombinant), Inactivated-zhzo)
    BLA Number: 125586
    351(a)
  • Andexxa (Coagulation Factor Xa (Recombinant), Inactivated-zhzo)
    BLA Number: 125586
    351(a)
  • Anktiva (nogapendekin alfa inbakicept-pmln)
    BLA Number: 761336
    351(a)
  • Anthim (obiltoxaximab)
    BLA Number: 125509
    351(a)
  • Anthrasil (Anthrax Immune Globulin Intravenous (Human))
    BLA Number: 125562
    351(a)
  • Apidra (insulin glulisine)
    BLA Number: 021629
    351(a)
  • Apidra (insulin glulisine)
    BLA Number: 021629
    351(a)
  • Apidra (insulin glulisine)
    BLA Number: 021629
    351(a)
  • Aplisol (Tuberculin, Purified Protein Derivative)
    BLA Number: 103782
    351(a)
  • Aralast, Aralast Np (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 125039
    351(a)
  • Aralast, Aralast Np (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 125039
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Aranesp (darbepoetin alpha)
    BLA Number: 103951
    351(a)
  • Arcalyst (rilonacept)
    BLA Number: 125249
    351(a)
  • Arepanrix (Influenza A [H5] Monovalent Vaccine, Adjuvanted)
    BLA Number: 125419
    351(a)
  • Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted)
    BLA Number: 125775
    351(a)
  • Armlupeg (pegfilgrastim-unne)
    BLA Number: 761212
    351(k) Biosimilar
  • Artiss (Fibrin Sealant (Human))
    BLA Number: 125266
    351(a)
  • Artiss (Fibrin Sealant (Human))
    BLA Number: 125266
    351(a)
  • Artiss (Fibrin Sealant (Human))
    BLA Number: 125266
    351(a)
  • Artiss (Fibrin Sealant (Human))
    BLA Number: 125266
    351(a)
  • Artiss (Fibrin Sealant (Human))
    BLA Number: 125266
    351(a)
  • Artiss (Fibrin Sealant (Human))
    BLA Number: 125266
    351(a)
  • Arzerra (ofatumumab)
    BLA Number: 125326
    351(a)
  • Arzerra (ofatumumab)
    BLA Number: 125326
    351(a)
  • Asceniv (Immune Globulin Intravenous, Human-slra)
    BLA Number: 125590
    351(a)
  • Asparlas (calaspargase pegol-mknl)
    BLA Number: 761102
    351(a)
  • Atgam (Lymphocyte Immune Globulin, Anti-thymocyte Globulin (Equine))
    BLA Number: 103676
    351(a)
  • Atryn (Antithrombin (Recombinant))
    BLA Number: 125284
    351(a)
  • Atryn (Antithrombin (Recombinant))
    BLA Number: 125284
    351(a)
  • ATTENUVAX (Measles Virus Vaccine Live)
    BLA Number: 101068
    351(a)
  • Aucatzyl (Obecabtagene autoleucel)
    BLA Number: 125813
    351(a)
  • Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted)
    BLA Number: 125692
    351(a)
  • Aukelso (denosumab-kyqq)
    BLA Number: 761436
    351(k) Interchangeable
  • Autoplex, Feiba Nf, Feiba Vh (Anti-Inhibitor Coagulant Complex)
    BLA Number: 101447
    351(a)
  • Autoplex, Feiba Nf, Feiba Vh (Anti-Inhibitor Coagulant Complex)
    BLA Number: 101447
    351(a)
  • Autoplex, Feiba Nf, Feiba Vh (Anti-Inhibitor Coagulant Complex)
    BLA Number: 101447
    351(a)
  • Autoplex, Feiba Nf, Feiba Vh (Anti-Inhibitor Coagulant Complex)
    BLA Number: 101447
    351(a)
  • Autoplex, Feiba Nf, Feiba Vh (Anti-Inhibitor Coagulant Complex)
    BLA Number: 101447
    351(a)
  • avance nerve graft (acellular nerve allograft-arwx)
    BLA Number: 125816
    351(a)
  • Avastin (bevacizumab)
    BLA Number: 125085
    351(a)
  • Avastin (bevacizumab)
    BLA Number: 125085
    351(a)
  • Avlayah (tividenofusp alfa-eknm)
    BLA Number: 761485
    351(a)
  • Avonex (interferon beta-1a)
    BLA Number: 103628
    351(a)
  • Avonex (interferon beta-1a)
    BLA Number: 103628
    351(a)
  • Avonex (interferon beta-1a)
    BLA Number: 103628
    351(a)
  • Avsola (infliximab-axxq)
    BLA Number: 761086
    351(k) Biosimilar
  • Avtozma (tocilizumab-anoh)
    BLA Number: 761498
    351(k) Biosimilar
  • Avtozma (tocilizumab-anoh)
    BLA Number: 761420
    351(k) Interchangeable
  • Avtozma (tocilizumab-anoh)
    BLA Number: 761420
    351(k) Interchangeable
  • Avtozma (tocilizumab-anoh)
    BLA Number: 761420
    351(k) Interchangeable
  • Avtozma (tocilizumab-anoh)
    BLA Number: 761498
    351(k) Interchangeable
  • Avzivi (bevacizumab-tnjn)
    BLA Number: 761198
    351(k) Biosimilar
  • Avzivi (bevacizumab-tnjn)
    BLA Number: 761198
    351(k) Biosimilar
  • Awiqli (insulin icodec-abae)
    BLA Number: 761326
    351(a)
  • Awiqli (insulin icodec-abae)
    BLA Number: 761326
    351(a)
  • Awiqli (insulin icodec-abae)
    BLA Number: 761326
    351(a)
  • BabyBig (Botulism Immune Globulin Intravenous (Human))
    BLA Number: 125034
    351(a)
  • Balfaxar (Prothrombin complex concentrate, human-lans)
    BLA Number: 125776
    351(a)
  • Balfaxar (Prothrombin complex concentrate, human-lans)
    BLA Number: 125776
    351(a)
  • Basaglar (insulin glargine)
    BLA Number: 205692
    351(a)
  • Basaglar (insulin glargine)
    BLA Number: 205692
    351(a)
  • Bat (Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine))
    BLA Number: 125462
    351(a)
  • Bavencio (avelumab)
    BLA Number: 761049
    351(a)
  • Baygam, Gamastan S/D (Immune Globulin (Human))
    BLA Number: 101134
    351(a)
  • Bayhep B, Hyperhep B S/D (Hepatitis B Immune Globulin (Human))
    BLA Number: 101146
    351(a)
  • Bayhep B, Hyperhep B S/D (Hepatitis B Immune Globulin (Human))
    BLA Number: 101146
    351(a)
  • Bayhep B, Hyperhep B S/D (Hepatitis B Immune Globulin (Human))
    BLA Number: 101146
    351(a)
  • Bayhep B, Hyperhep B S/D (Hepatitis B Immune Globulin (Human))
    BLA Number: 101146
    351(a)
  • Bayhep B, Hyperhep B S/D (Hepatitis B Immune Globulin (Human))
    BLA Number: 101146
    351(a)
  • Bayrab, Hyperrab (Rabies Immune Globulin (Human))
    BLA Number: 101144
    351(a)
  • Bayrab, Hyperrab (Rabies Immune Globulin (Human))
    BLA Number: 101144
    351(a)
  • Bayrab,Hyperrab (Rabies Immune Globulin (Human))
    BLA Number: 101144
    351(a)
  • Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose (Rho(D) Immune Globulin (Human))
    BLA Number: 101141
    351(a)
  • Bayrho-D, Hyprho-D, Hyperrho S/D Full Dose, Hyperrho S/D Mini-Dose (Rho(D) Immune Globulin (Human))
    BLA Number: 101141
    351(a)
  • Baytet, Hypertet (Tetanus Immune Globulin (Human))
    BLA Number: 101142
    351(a)
  • Benefix (Coagulation Factor IX (Recombinant))
    BLA Number: 103677
    351(a)
  • Benefix (Coagulation Factor IX (Recombinant))
    BLA Number: 103677
    351(a)
  • Benefix (Coagulation Factor IX (Recombinant))
    BLA Number: 103677
    351(a)
  • Benefix (Coagulation Factor IX (Recombinant))
    BLA Number: 103677
    351(a)
  • Benefix (Coagulation Factor IX (Recombinant))
    BLA Number: 103677
    351(a)
  • Benlysta (belimumab)
    BLA Number: 125370
    351(a)
  • Benlysta (belimumab)
    BLA Number: 761043
    351(a)
  • Benlysta (belimumab)
    BLA Number: 761043
    351(a)
  • Benlysta (belimumab)
    BLA Number: 125370
    351(a)
  • Beovu (brolucizumab-dbll)
    BLA Number: 761125
    351(a)
  • Beovu (brolucizumab-dbll)
    BLA Number: 761125
    351(a)
  • BEQVEZ (fidanacogene elaparvovec-dzkt)
    BLA Number: 125786
    351(a)
  • Berinert (C1 Esterase Inhibitor (Human))
    BLA Number: 125287
    351(a)
  • Besponsa (inotuzumab ozogamicin)
    BLA Number: 761040
    351(a)
  • Besremi (ropeginterferon alfa-2b-njft)
    BLA Number: 761166
    351(a)
  • Betaseron (interferon beta-1b)
    BLA Number: 103471
    351(a)
  • Bexsero (Meningococcal Group B Vaccine)
    BLA Number: 125546
    351(a)
  • Bexxar (tositumomab and iodine I-131 tositumomab)
    BLA Number: 125011
    351(a)
  • Bexxar (tositumomab and iodine I-131 tositumomab)
    BLA Number: 125011
    351(a)
  • Beyfortus (nirsevimab-alip)
    BLA Number: 761328
    351(a)
  • Beyfortus (nirsevimab-alip)
    BLA Number: 761328
    351(a)
  • Bildyos (denosumab-nxxp)
    BLA Number: 761444
    351(k) Interchangeable
  • Bildyos (denosumab-nxxp)
    BLA Number: 761444
    351(k) Interchangeable
  • Bilprevda (denosumab-nxxp)
    BLA Number: 761444
    351(k) Interchangeable
  • Bimzelx (bimekizumab-bkzx)
    BLA Number: 761151
    351(a)
  • Bimzelx (bimekizumab-bkzx)
    BLA Number: 761151
    351(a)
  • Bimzelx (bimekizumab-bkzx)
    BLA Number: 761151
    351(a)
  • Bimzelx (bimekizumab-bkzx)
    BLA Number: 761151
    351(a)
  • Bioclate (Armour), Recombinate (Antihemophilic Factor (Recombinant))
    BLA Number: 103375
    351(a)
  • Bioclate (Armour), Recombinate (Antihemophilic Factor (Recombinant))
    BLA Number: 103375
    351(a)
  • Bioclate (Armour), Recombinate (Antihemophilic Factor (Recombinant))
    BLA Number: 103375
    351(a)
  • Bioclate (Armour), Recombinate (Antihemophilic Factor (Recombinant))
    BLA Number: 103375
    351(a)
  • Bioclate (Armour), Recombinate (Antihemophilic Factor (Recombinant))
    BLA Number: 103375
    351(a)
  • Biorab (Rabies Vaccine Adsorbed)
    BLA Number: 103820
    351(a)
  • Biothrax (Anthrax Vaccine Adsorbed)
    BLA Number: 103821
    351(a)
  • Biothrax (Anthrax Vaccine Adsorbed)
    BLA Number: 103821
    351(a)
  • Bivigam (Immune Globulin Intravenous (Human))
    BLA Number: 125389
    351(a)
  • Bivigam (Immune Globulin Intravenous (Human))
    BLA Number: 125389
    351(a)
  • Bizengri (zenocutuzumab-zbco)
    BLA Number: 761352
    351(a)
  • Bkemv (eculizumab-aeeb)
    BLA Number: 761333
    351(k) Interchangeable
  • Blenrep (belantamab mafodotin-blmf)
    BLA Number: 761158
    351(a)
  • Blenrep (belantamab mafodotin-blmf)
    BLA Number: 761440
    351(a)
  • Blincyto (blinatumomab)
    BLA Number: 125557
    351(a)
  • Bomyntra (denosumab-bnht)
    BLA Number: 761398
    351(k) Interchangeable
  • Bomyntra (denosumab-bnht)
    BLA Number: 761398
    351(k) Interchangeable
  • Boncresa (denosumab-mobz)
    BLA Number: 761456
    351(k) Interchangeable
  • Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
    BLA Number: 125106
    351(a)
  • Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)
    BLA Number: 125106
    351(a)
  • Bosaya (denosumab-kyqq)
    BLA Number: 761436
    351(k) Interchangeable
  • Botox (onabotulinumtoxinA)
    BLA Number: 103000
    351(a)
  • Botox (onabotulinumtoxinA)
    BLA Number: 103000
    351(a)
  • Botox (onabotulinumtoxinA)
    BLA Number: 103000
    351(a)
  • Botox Cosmetic (onabotulinumtoxinA)
    BLA Number: 103000
    351(a)
  • Botox Cosmetic (onabotulinumtoxinA)
    BLA Number: 103000
    351(a)
  • Bravelle (urofollitropin)
    BLA Number: 021289
    351(a)
  • Breyanzi (lisocabtagene maraleucel)
    BLA Number: 125714
    351(a)
  • Brineura (cerliponase alfa)
    BLA Number: 761052
    351(a)
  • Briumvi (ublituximab-xiiy)
    BLA Number: 761238
    351(a)
  • Buminate, Flexbumin (Albumin (Human))
    BLA Number: 101452
    351(a)
  • Buminate, Flexbumin (Albumin (Human))
    BLA Number: 101452
    351(a)
  • Buminate, Flexbumin (Albumin (Human))
    BLA Number: 101452
    351(a)
  • Buminate, Flexbumin (Albumin (Human))
    BLA Number: 101452
    351(a)
  • Buminate, Flexbumin (Albumin (Human))
    BLA Number: 101452
    351(a)
  • Byooviz (ranibizumab-nuna)
    BLA Number: 761202
    351(k) Interchangeable
  • Cablivi (caplacizumab-yhdp)
    BLA Number: 761112
    351(a)
  • Campath (alemtuzumab)
    BLA Number: 103948
    351(a)
  • Campath (alemtuzumab)
    BLA Number: 103948
    351(a)
  • Candin (Candida albicans Skin Test Antigen for Cellular Hypersensitivity)
    BLA Number: 103257
    351(a)
  • CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine)
    BLA Number: 125814
    351(a)
  • Carimune, Carimune Nf, Panglobulin, Sandoglobulin (Immune Globulin Intravenous (Human))
    BLA Number: 102367
    351(a)
  • Carimune, Carimune Nf, Panglobulin, Sandoglobulin (Immune Globulin Intravenous (Human))
    BLA Number: 102367
    351(a)
  • Carimune, Carimune Nf, Panglobulin, Sandoglobulin (Immune Globulin Intravenous (Human))
    BLA Number: 102367
    351(a)
  • Carticel Sm Service (Autologous Cultured Chondrocytes)
    BLA Number: 103661
    351(a)
  • Carvykti (ciltacabtagene autoleucel)
    BLA Number: 125746
    351(a)
  • Casgevy (Exagamglogene autotemcel)
    BLA Number: 125787
    351(a)
  • Cathflo Activase (alteplase)
    BLA Number: 103172
    351(a)
  • Ceprotin (Protein C Concentrate (Human))
    BLA Number: 125234
    351(a)
  • Ceprotin (Protein C Concentrate (Human))
    BLA Number: 125234
    351(a)
  • Cerezyme (imiglucerase)
    BLA Number: 020367
    351(a)
  • Cerezyme (imiglucerase)
    BLA Number: 020367
    351(a)
  • Cervarix (Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant)
    BLA Number: 125259
    351(a)
  • Chorionic Gonadotropin (chorionic gonadotropin)
    BLA Number: 017067
    351(a)
  • Chorionic Gonadotropin (chorionic gonadotropin)
    BLA Number: 017067
    351(a)
  • Chorionic Gonadotropin (chorionic gonadotropin)
    BLA Number: 017067
    351(a)
  • Chorionic Gonadotropin (chorionic gonadotropin)
    BLA Number: 017067
    351(a)
  • Chorionic Gonadotropin (chorionic gonadotropin)
    BLA Number: 017054
    351(a)
  • Chorionic Gonadotropin (chorionic gonadotropin)
    BLA Number: 017054
    351(a)
  • Chromalbin (albumin chromated CR-51 serum)
    BLA Number: 017835
    351(a)
  • Chromalbin (albumin chromated CR-51 serum)
    BLA Number: 017835
    351(a)
  • Chromalbin (albumin chromated CR-51 serum)
    BLA Number: 017835
    351(a)
  • Chymodiactin (chymopapain)
    BLA Number: 018663
    351(a)
  • Chymodiactin (chymopapain)
    BLA Number: 018663
    351(a)
  • Cimerli (ranibizumab-eqrn)
    BLA Number: 761165
    351(k) Interchangeable
  • Cimerli (ranibizumab-eqrn)
    BLA Number: 761165
    351(k) Interchangeable
  • Cimzia (certolizumab pegol)
    BLA Number: 125160
    351(a)
  • Cimzia (certolizumab pegol)
    BLA Number: 125160
    351(a)
  • Cinqair (reslizumab)
    BLA Number: 761033
    351(a)
  • Cinryze (C1 Esterase Inhibitor (Human))
    BLA Number: 125267
    351(a)
  • Clevecord (HPC, Cord Blood)
    BLA Number: 125594
    351(a)
  • Cnj-016 (Vaccinia Immune Globulin Intravenous (Human))
    BLA Number: 125109
    351(a)
  • Coagadex (Coagulation Factor X (Human))
    BLA Number: 125506
    351(a)
  • Coagadex (Coagulation Factor X (Human))
    BLA Number: 125506
    351(a)
  • Columvi (glofitamab-gxbm)
    BLA Number: 761309
    351(a)
  • Columvi (glofitamab-gxbm)
    BLA Number: 761309
    351(a)
  • Comirnaty (COVID-19 Vaccine, mRNA)
    BLA Number: 125742
    351(a)
  • Comirnaty (COVID-19 Vaccine, mRNA)
    BLA Number: 125742
    351(a)
  • Comirnaty (COVID-19 Vaccine, mRNA)
    BLA Number: 125742
    351(a)
  • Comirnaty (COVID-19 Vaccine, mRNA)
    BLA Number: 125742
    351(a)
  • Comirnaty (COVID-19 Vaccine, mRNA)
    BLA Number: 125742
    351(a)
  • Comirnaty (COVID-19 Vaccine, mRNA)
    BLA Number: 125742
    351(a)
  • COMVAX (Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine)
    BLA Number: 103623
    351(a)
  • Conexxence (denosumab-bnht)
    BLA Number: 761398
    351(k) Interchangeable
  • Cordcyte (HPC, Cord Blood)
    BLA Number: 125432
    351(a)
  • Corifact (Factor XIII Concentrate (Human))
    BLA Number: 125385
    351(a)
  • Cosentyx (secukinumab)
    BLA Number: 125504
    351(a)
  • Cosentyx (secukinumab)
    BLA Number: 125504
    351(a)
  • Cosentyx (secukinumab)
    BLA Number: 125504
    351(a)
  • Cosentyx (secukinumab)
    BLA Number: 125504
    351(a)
  • Cosentyx (secukinumab)
    BLA Number: 125504
    351(a)
  • Cosentyx (secukinumab)
    BLA Number: 761349
    351(a)
  • Cosentyx (secukinumab)
    BLA Number: 125504
    351(a)
  • Cotazym (pancrelipase)
    BLA Number: 020580
    351(a)
  • Creon (pancrelipase)
    BLA Number: 020725
    351(a)
  • Creon (pancrelipase)
    BLA Number: 020725
    351(a)
  • Creon (pancrelipase)
    BLA Number: 020725
    351(a)
  • Creon (pancrelipase)
    BLA Number: 020725
    351(a)
  • Creon (pancrelipase)
    BLA Number: 020725
    351(a)
  • Crofab (Crotalidae Polyvalent Immune Fab (Ovine))
    BLA Number: 103788
    351(a)
  • Crosseal, Evicel (Fibrin Sealant (Human))
    BLA Number: 125010
    351(a)
  • Crosseal, Evicel (Fibrin Sealant (Human))
    BLA Number: 125010
    351(a)
  • Crosseal, Evicel (Fibrin Sealant (Human))
    BLA Number: 125010
    351(a)
  • Crysvita (burosumab-twza)
    BLA Number: 761068
    351(a)
  • Crysvita (burosumab-twza)
    BLA Number: 761068
    351(a)
  • Crysvita (burosumab-twza)
    BLA Number: 761068
    351(a)
  • Curosurf (poractant alfa)
    BLA Number: 020744
    351(a)
  • Curosurf (poractant alfa)
    BLA Number: 020744
    351(a)
  • Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
    BLA Number: 125668
    351(a)
  • Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
    BLA Number: 125668
    351(a)
  • Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
    BLA Number: 125668
    351(a)
  • Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
    BLA Number: 125668
    351(a)
  • Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
    BLA Number: 125668
    351(a)
  • Cutaquig (Immune Globulin Subcutaneous (Human)-hipp)
    BLA Number: 125668
    351(a)
  • Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution)
    BLA Number: 125596
    351(a)
  • Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution)
    BLA Number: 125596
    351(a)
  • Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution)
    BLA Number: 125596
    351(a)
  • Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution)
    BLA Number: 125596
    351(a)
  • Cuvitru (Immune Globulin Subcutaneous (Human), 20% Solution)
    BLA Number: 125596
    351(a)
  • CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted)
    BLA Number: 125761
    351(a)
  • Cyltezo (adalimumab-adbm)
    BLA Number: 761058
    351(k) Interchangeable
  • Cyltezo (adalimumab-adbm)
    BLA Number: 761058
    351(k) Interchangeable
  • Cyltezo (adalimumab-adbm)
    BLA Number: 761058
    351(k) Interchangeable
  • Cyltezo (adalimumab-adbm)
    BLA Number: 761058
    351(k) Interchangeable
  • Cyltezo (adalimumab-adbm)
    BLA Number: 761058
    351(k) Interchangeable
  • Cyltezo (adalimumab-adbm)
    BLA Number: 761058
    351(k) Interchangeable
  • Cyramza (ramucirumab)
    BLA Number: 125477
    351(a)
  • Cyramza (ramucirumab)
    BLA Number: 125477
    351(a)
  • Cytogam (Cytomegalovirus Immune Globulin Intravenous (Human))
    BLA Number: 103189
    351(a)
  • Danyelza (naxitamab-gqgk)
    BLA Number: 761171
    351(a)
  • Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed)
    BLA Number: 103666
    351(a)
  • Darzalex (daratumumab)
    BLA Number: 761036
    351(a)
  • Darzalex (daratumumab)
    BLA Number: 761036
    351(a)
  • Darzalex Faspro (daratumumab and hyaluronidase-fihj)
    BLA Number: 761145
    351(a)
  • Datroway (datopotamab deruxtecan-dlnk)
    BLA Number: 761394
    351(a)
  • Daxxify (daxibotulinumtoxinA-lanm)
    BLA Number: 761127
    351(a)
  • Daxxify (daxibotulinumtoxinA-lanm)
    BLA Number: 761127
    351(a)
  • Decnupaz (pivekimab sunirine-pvzy)
    BLA Number: 761460
    351(a)
  • Dengvaxia (Dengue Tetravalent Vaccine, Live)
    BLA Number: 125682
    351(a)
  • Digibind (Digoxin Immune Fab (Ovine))
    BLA Number: 103141
    351(a)
  • Digifab (Digoxin Immune Fab (Ovine))
    BLA Number: 103910
    351(a)
  • Draximage MAA (kit for the preparation of technetium Tc-99m albumin aggregated)
    BLA Number: 017881
    351(a)
  • Ducord (HPC, Cord Blood)
    BLA Number: 125407
    351(a)
  • Dupixent (dupilumab)
    BLA Number: 761055
    351(a)
  • Dupixent (dupilumab)
    BLA Number: 761055
    351(a)
  • Dupixent (dupilumab)
    BLA Number: 761055
    351(a)
  • Dupixent (dupilumab)
    BLA Number: 761055
    351(a)
  • Dupixent (dupilumab)
    BLA Number: 761055
    351(a)
  • Dupixent (dupilumab)
    BLA Number: 761055
    351(a)
  • Dysport (abobotulinumtoxinA)
    BLA Number: 125274
    351(a)
  • Dysport (abobotulinumtoxinA)
    BLA Number: 125274
    351(a)
  • Ebanga (ansuvimab-zykl)
    BLA Number: 761172
    351(a)
  • Ebglyss (lebrikizumab-lbkz)
    BLA Number: 761306
    351(a)
  • Ebglyss (lebrikizumab-lbkz)
    BLA Number: 761306
    351(a)
  • Egrifta (tesamorelin)
    BLA Number: 022505
    351(a)
  • Egrifta SV (tesamorelin)
    BLA Number: 022505
    351(a)
  • Egrifta WR (tesamorelin)
    BLA Number: 022505
    351(a)
  • Elahere (mirvetuximab soravtansine-gynx)
    BLA Number: 761310
    351(a)
  • Elaprase (idursulfase)
    BLA Number: 125151
    351(a)
  • Elase-chloromycetin (fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol)
    BLA Number: 050294
    351(a)
  • Elelyso (taliglucerase alfa)
    BLA Number: 022458
    351(a)
  • ELEVIDYS (delandistrogene moxeparvovec-rokl)
    BLA Number: 125781
    351(a)
  • Elfabrio (pegunigalsidase alfa-iwxj)
    BLA Number: 761161
    351(a)
  • Elfabrio (pegunigalsidase alfa-iwxj)
    BLA Number: 761161
    351(a)
  • Elitek (rasburicase)
    BLA Number: 103946
    351(a)
  • Elitek (rasburicase)
    BLA Number: 103946
    351(a)
  • Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
    BLA Number: 125487
    351(a)
  • Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
    BLA Number: 125487
    351(a)
  • Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
    BLA Number: 125487
    351(a)
  • Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
    BLA Number: 125487
    351(a)
  • Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
    BLA Number: 125487
    351(a)
  • Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
    BLA Number: 125487
    351(a)
  • Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
    BLA Number: 125487
    351(a)
  • Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
    BLA Number: 125487
    351(a)
  • Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
    BLA Number: 125487
    351(a)
  • Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion protein)
    BLA Number: 125487
    351(a)
  • Elrexfio (elranatamab-bcmm)
    BLA Number: 761345
    351(a)
  • Elrexfio (elranatamab-bcmm)
    BLA Number: 761345
    351(a)
  • Elspar (asparaginase)
    BLA Number: 101063
    351(a)
  • Elzonris (tagraxofusp-erzs)
    BLA Number: 761116
    351(a)
  • Emgality (galcanezumab-gnlm)
    BLA Number: 761063
    351(a)
  • Emgality (galcanezumab-gnlm)
    BLA Number: 761063
    351(a)
  • Emgality (galcanezumab-gnlm)
    BLA Number: 761063
    351(a)
  • Empliciti (elotuzumab)
    BLA Number: 761035
    351(a)
  • Empliciti (elotuzumab)
    BLA Number: 761035
    351(a)
  • Emrelis (telisotuzumab vedotin-tllv)
    BLA Number: 761384
    351(a)
  • Emrelis (telisotuzumab vedotin-tllv)
    BLA Number: 761384
    351(a)
  • Enbrel (etanercept)
    BLA Number: 103795
    351(a)
  • Enbrel (etanercept)
    BLA Number: 103795
    351(a)
  • Enbrel (etanercept)
    BLA Number: 103795
    351(a)
  • Enbrel (etanercept)
    BLA Number: 103795
    351(a)
  • Enbrel (etanercept)
    BLA Number: 103795
    351(a)
  • Enbrel (etanercept)
    BLA Number: 103795
    351(a)
  • Enbrel Mini (etanercept)
    BLA Number: 103795
    351(a)
  • encelto (revakinagene taroretcel-lwey)
    BLA Number: 125798
    351(a)
  • Enflonsia (clesrovimab-cfor)
    BLA Number: 761432
    351(a)
  • Engerix-B (Hepatitis B Vaccine (Recombinant))
    BLA Number: 103239
    351(a)
  • Engerix-B (Hepatitis B Vaccine (Recombinant))
    BLA Number: 103239
    351(a)
  • Engerix-B (Hepatitis B Vaccine (Recombinant))
    BLA Number: 103239
    351(a)
  • Engerix-B (Hepatitis B Vaccine (Recombinant))
    BLA Number: 103239
    351(a)
  • Enhertu (fam-trastuzumab deruxtecan-nxki)
    BLA Number: 761139
    351(a)
  • Enjaymo (sutimlimab-jome)
    BLA Number: 761164
    351(a)
  • Ennumo (pegfilgrastim-pccg)
    BLA Number: 761147
    351(k) Biosimilar
  • Enoby (denosumab-qbde)
    BLA Number: 761439
    351(k) Interchangeable
  • Enspryng (satralizumab-mwge)
    BLA Number: 761149
    351(a)
  • Entyvio (vedolizumab)
    BLA Number: 125476
    351(a)
  • Entyvio (vedolizumab)
    BLA Number: 761133
    351(a)
  • Entyvio Pen (vedolizumab)
    BLA Number: 761133
    351(a)
  • Enzeevu (aflibercept-abzv)
    BLA Number: 761382
    351(k) Biosimilar
  • Enzeevu (aflibercept-abzv)
    BLA Number: 761382
    351(k) Biosimilar
  • Epkinly (epcoritamab-bysp)
    BLA Number: 761324
    351(a)
  • Epkinly (epcoritamab-bysp)
    BLA Number: 761324
    351(a)
  • Epogen/Procrit (epoetin alfa)
    BLA Number: 103234
    351(a)
  • Epogen/Procrit (epoetin alfa)
    BLA Number: 103234
    351(a)
  • Epogen/Procrit (epoetin alfa)
    BLA Number: 103234
    351(a)
  • Epogen/Procrit (epoetin alfa)
    BLA Number: 103234
    351(a)
  • Epogen/Procrit (epoetin alfa)
    BLA Number: 103234
    351(a)
  • Epogen/Procrit (epoetin alfa)
    BLA Number: 103234
    351(a)
  • Epysqli (eculizumab-aagh)
    BLA Number: 761340
    351(k) Interchangeable
  • Erbitux (cetuximab)
    BLA Number: 125084
    351(a)
  • Erbitux (cetuximab)
    BLA Number: 125084
    351(a)
  • Erelzi (etanercept-szzs)
    BLA Number: 761042
    351(k) Biosimilar
  • Erelzi (etanercept-szzs)
    BLA Number: 761042
    351(k) Biosimilar
  • Erelzi (etanercept-szzs)
    BLA Number: 761042
    351(k) Biosimilar
  • Erelzi Sensoready (etanercept-szzs)
    BLA Number: 761042
    351(k) Biosimilar
  • Ervebo (Ebola Zaire Vaccine, Live)
    BLA Number: 125690
    351(a)
  • Erwinaze (asparaginase Erwinia chrysanthemi)
    BLA Number: 125359
    351(a)
  • Esperoct (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
    BLA Number: 125671
    351(a)
  • Esperoct (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
    BLA Number: 125671
    351(a)
  • Esperoct (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
    BLA Number: 125671
    351(a)
  • Esperoct (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
    BLA Number: 125671
    351(a)
  • Esperoct (Antihemophilic Factor (Recombinant), GlycoPEGylated-exei)
    BLA Number: 125671
    351(a)
  • Eticovo (etanercept-ykro)
    BLA Number: 761066
    351(k) Biosimilar
  • Eticovo (etanercept-ykro)
    BLA Number: 761066
    351(k) Interchangeable
  • Eticovo (etanercept-ykro)
    BLA Number: 761066
    351(k) Interchangeable
  • Evarrest (Fibrin Sealant Patch)
    BLA Number: 125392
    351(a)
  • Evarrest (Fibrin Sealant Patch)
    BLA Number: 125392
    351(a)
  • Evarrest (Fibrin Sealant Patch)
    BLA Number: 125392
    351(a)
  • Evenity (romosozumab-aqqg)
    BLA Number: 761062
    351(a)
  • Evithrom (Thrombin, Topical (Human))
    BLA Number: 125247
    351(a)
  • Evithrom (Thrombin, Topical (Human))
    BLA Number: 125247
    351(a)
  • Evithrom (Thrombin, Topical (Human))
    BLA Number: 125247
    351(a)
  • Evithrom (Thrombin, Topical (Human))
    BLA Number: 125247
    351(a)
  • Evkeeza (evinacumab-dgnb)
    BLA Number: 761181
    351(a)
  • Evkeeza (evinacumab-dgnb)
    BLA Number: 761181
    351(a)
  • Exdensur (depemokimab-ulaa)
    BLA Number: 761458
    351(a)
  • Exdensur (depemokimab-ulaa)
    BLA Number: 761458
    351(a)
  • Extavia (interferon beta-1b)
    BLA Number: 125290
    351(a)
  • Eydenzelt (aflibercept-boav)
    BLA Number: 761377
    351(k) Biosimilar
  • Eydenzelt (aflibercept-boav)
    BLA Number: 761377
    351(k) Biosimilar
  • Eylea (aflibercept)
    BLA Number: 125387
    351(a)
  • Eylea (aflibercept)
    BLA Number: 125387
    351(a)
  • Eylea HD (aflibercept)
    BLA Number: 761355
    351(a)
  • Fabrazyme (agalsidase beta)
    BLA Number: 103979
    351(a)
  • Fabrazyme (agalsidase beta)
    BLA Number: 103979
    351(a)
  • Fasenra (benralizumab)
    BLA Number: 761070
    351(a)
  • Fasenra (benralizumab)
    BLA Number: 761070
    351(a)
  • Fasenra (benralizumab)
    BLA Number: 761070
    351(a)
  • FESILTY (fibrinogen, human–chmt)
    BLA Number: 125833
    351(a)
  • Fiasp (insulin aspart)
    BLA Number: 208751
    351(a)
  • Fiasp (insulin aspart)
    BLA Number: 208751
    351(a)
  • Fiasp (insulin aspart)
    BLA Number: 208751
    351(a)
  • Fiasp (insulin aspart)
    BLA Number: 208751
    351(a)
  • Fibryga (Fibrinogen (Human))
    BLA Number: 125612
    351(a)
  • Fibryga (Fibrinogen (Human))
    BLA Number: 125612
    351(a)
  • Filkri (filgrastim-laha)
    BLA Number: 761027
    351(k) Biosimilar
  • Filkri (filgrastim-laha)
    BLA Number: 761027
    351(k) Biosimilar
  • Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
    BLA Number: 125077
    351(a)
  • Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
    BLA Number: 125077
    351(a)
  • Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
    BLA Number: 125077
    351(a)
  • Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
    BLA Number: 125077
    351(a)
  • Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
    BLA Number: 125077
    351(a)
  • Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
    BLA Number: 125077
    351(a)
  • Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
    BLA Number: 125077
    351(a)
  • Flebogamma 5%, Flebogamma 5% Dif (Immune Globulin Intravenous (Human))
    BLA Number: 125077
    351(a)
  • Fluad (Influenza Vaccine, Adjuvanted)
    BLA Number: 125510
    351(a)
  • Fluad,Fluad Quadrivalent (Influenza Vaccine, Adjuvanted)
    BLA Number: 125510
    351(a)
  • Fluarix, Fluarix Quadrivalent (Influenza Vaccine)
    BLA Number: 125127
    351(a)
  • Fluarix, Fluarix Quadrivalent (Influenza Vaccine)
    BLA Number: 125127
    351(a)
  • Flublok (Influenza Vaccine)
    BLA Number: 125285
    351(a)
  • Flublok (Influenza Vaccine)
    BLA Number: 125285
    351(a)
  • Flublok (Influenza Vaccine)
    BLA Number: 125285
    351(a)
  • Flucelvax, Flucelvax Quadrivalent (Influenza Vaccine)
    BLA Number: 125408
    351(a)
  • Flucelvax, Flucelvax Quadrivalent (Influenza Vaccine)
    BLA Number: 125408
    351(a)
  • Flucelvax, Flucelvax Quadrivalent (Influenza Vaccine)
    BLA Number: 125408
    351(a)
  • Flucelvax, Flucelvax Quadrivalent (Influenza Vaccine)
    BLA Number: 125408
    351(a)
  • Flucelvax, Flucelvax Quadrivalent (Influenza Vaccine)
    BLA Number: 125408
    351(a)
  • Flulaval, Flulaval Quadrivalent (Influenza Vaccine)
    BLA Number: 125163
    351(a)
  • Flulaval, Flulaval Quadrivalent (Influenza Vaccine)
    BLA Number: 125163
    351(a)
  • Flulaval, Flulaval Quadrivalent (Influenza Vaccine)
    BLA Number: 125163
    351(a)
  • Flulaval, Flulaval Quadrivalent (Influenza Vaccine)
    BLA Number: 125163
    351(a)
  • Flulaval, Flulaval Quadrivalent (Influenza Vaccine)
    BLA Number: 125163
    351(a)
  • Flumist, Flumist Quad (Influenza Vaccine Live, Intranasal)
    BLA Number: 125020
    351(a)
  • Flumist, Flumist Quad (Influenza Vaccine Live, Intranasal)
    BLA Number: 125020
    351(a)
  • Fluvirin (Influenza Virus Vaccine)
    BLA Number: 103837
    351(a)
  • Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
    BLA Number: 103914
    351(a)
  • Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
    BLA Number: 103914
    351(a)
  • Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
    BLA Number: 103914
    351(a)
  • Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
    BLA Number: 103914
    351(a)
  • Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
    BLA Number: 103914
    351(a)
  • Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
    BLA Number: 103914
    351(a)
  • Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
    BLA Number: 103914
    351(a)
  • Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
    BLA Number: 103914
    351(a)
  • Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
    BLA Number: 103914
    351(a)
  • Fluzone, Fluzone Hd Quadrivalent, Fluzone High Dose, Fluzone Intradermal, Fluzone Quadrivalent (Influenza Virus Vaccine)
    BLA Number: 103914
    351(a)
  • Follistim (follitropin beta)
    BLA Number: 020582
    351(a)
  • Follistim (follitropin beta)
    BLA Number: 020582
    351(a)
  • Follistim AQ (follitropin beta)
    BLA Number: 021273
    351(a)
  • Follistim AQ (follitropin beta)
    BLA Number: 021273
    351(a)
  • Follistim AQ Cartridge (follitropin beta)
    BLA Number: 021211
    351(a)
  • Follistim AQ Cartridge (follitropin beta)
    BLA Number: 021211
    351(a)
  • Follistim AQ Cartridge (follitropin beta)
    BLA Number: 021211
    351(a)
  • Follistim AQ Cartridge (follitropin beta)
    BLA Number: 021211
    351(a)
  • Fulphila (pegfilgrastim-jmdb)
    BLA Number: 761075
    351(k) Biosimilar
  • Fylnetra (pegfilgrastim-pbbk)
    BLA Number: 761084
    351(k) Biosimilar
  • Gamifant (emapalumab-lzsg)
    BLA Number: 761107
    351(a)
  • Gamifant (emapalumab-lzsg)
    BLA Number: 761107
    351(a)
  • Gamifant (emapalumab-lzsg)
    BLA Number: 761107
    351(a)
  • Gamifant (emapalumab-lzsg)
    BLA Number: 761107
    351(a)
  • Gamifant (emapalumab-lzsg)
    BLA Number: 761107
    351(a)
  • Gamifant (emapalumab-lzsg)
    BLA Number: 761107
    351(a)
  • Gamimune (Immune Globulin Intravenous (Human))
    BLA Number: 101147
    351(a)
  • Gamimune (Immune Globulin Intravenous (Human))
    BLA Number: 101147
    351(a)
  • Gammagard Liquid (Immune Globulin Infusion (Human))
    BLA Number: 125105
    351(a)
  • Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
    BLA Number: 103133
    351(a)
  • Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
    BLA Number: 103133
    351(a)
  • Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
    BLA Number: 103133
    351(a)
  • Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
    BLA Number: 103133
    351(a)
  • Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
    BLA Number: 103133
    351(a)
  • Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
    BLA Number: 103133
    351(a)
  • Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
    BLA Number: 103133
    351(a)
  • Gammagard, Gammagard S/D, Iveegam (Immune Globulin Intravenous (Human))
    BLA Number: 103133
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaked, Gamunex-C (Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified)
    BLA Number: 125046
    351(a)
  • Gammaplex (Immune Globulin Intravenous (Human))
    BLA Number: 125329
    351(a)
  • Gammaplex (Immune Globulin Intravenous (Human))
    BLA Number: 125329
    351(a)
  • Gammaplex (Immune Globulin Intravenous (Human))
    BLA Number: 125329
    351(a)
  • Gammaplex (Immune Globulin Intravenous (Human))
    BLA Number: 125329
    351(a)
  • Gammaplex (Immune Globulin Intravenous (Human))
    BLA Number: 125329
    351(a)
  • Gammaplex (Immune Globulin Intravenous (Human))
    BLA Number: 125329
    351(a)
  • Gammaplex (Immune Globulin Intravenous (Human))
    BLA Number: 125329
    351(a)
  • gammar i.v.,gammar-p i.v. (Immune Globulin Intravenous (Human))
    BLA Number: 103956
    351(a)
  • gammar i.v.,gammar-p i.v. (Immune Globulin Intravenous (Human))
    BLA Number: 103956
    351(a)
  • gammar i.v.,gammar-p i.v. (Immune Globulin Intravenous (Human))
    BLA Number: 103956
    351(a)
  • gammar i.v.,gammar-p i.v. (Immune Globulin Intravenous (Human))
    BLA Number: 103956
    351(a)
  • Gardasil (Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant)
    BLA Number: 125126
    351(a)
  • Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
    BLA Number: 125508
    351(a)
  • Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
    BLA Number: 125508
    351(a)
  • Gazyva (obinutuzumab)
    BLA Number: 125486
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Genotropin (somatropin)
    BLA Number: 020280
    351(a)
  • Gintuit (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)
    BLA Number: 125400
    351(a)
  • Glassia (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 125325
    351(a)
  • Glassia (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 125325
    351(a)
  • Glassia (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 125325
    351(a)
  • Gonal-f (follitropin alfa)
    BLA Number: 020378
    351(a)
  • Gonal-f (follitropin alfa)
    BLA Number: 020378
    351(a)
  • Gonal-f (follitropin alfa)
    BLA Number: 020378
    351(a)
  • Gonal-f (follitropin alfa)
    BLA Number: 020378
    351(a)
  • Gonal-f (follitropin alfa)
    BLA Number: 020378
    351(a)
  • Gonal-f RFF (follitropin alfa)
    BLA Number: 021765
    351(a)
  • Gonal-f RFF (follitropin alfa)
    BLA Number: 021765
    351(a)
  • Gonal-f RFF (follitropin alfa)
    BLA Number: 021765
    351(a)
  • Gonal-f RFF RediJect (follitropin alfa)
    BLA Number: 021684
    351(a)
  • Gonal-f RFF RediJect (follitropin alfa)
    BLA Number: 021684
    351(a)
  • Gonal-f RFF RediJect (follitropin alfa)
    BLA Number: 021684
    351(a)
  • Granix (tbo-filgrastim)
    BLA Number: 125294
    351(a)
  • Granix (tbo-filgrastim)
    BLA Number: 125294
    351(a)
  • Granix (tbo-filgrastim)
    BLA Number: 125294
    351(a)
  • Granix (tbo-filgrastim)
    BLA Number: 125294
    351(a)
  • Grastek (Timothy Grass Pollen Allergen Extract)
    BLA Number: 125473
    351(a)
  • Hadlima (adalimumab-bwwd)
    BLA Number: 761059
    351(k) Interchangeable
  • Hadlima (adalimumab-bwwd)
    BLA Number: 761059
    351(k) Interchangeable
  • Hadlima (adalimumab-bwwd)
    BLA Number: 761059
    351(k) Interchangeable
  • Hadlima (adalimumab-bwwd)
    BLA Number: 761059
    351(k) Interchangeable
  • Hadlima (adalimumab-bwwd)
    BLA Number: 761059
    351(k) Interchangeable
  • Hadlima (adalimumab-bwwd)
    BLA Number: 761059
    351(k) Interchangeable
  • Haegarda (C1 Esterase Inhibitor Subcutaneous (Human))
    BLA Number: 125606
    351(a)
  • Haegarda (C1 Esterase Inhibitor Subcutaneous (Human))
    BLA Number: 125606
    351(a)
  • Havrix (Hepatitis A Vaccine)
    BLA Number: 103475
    351(a)
  • Havrix (Hepatitis A Vaccine)
    BLA Number: 103475
    351(a)
  • Havrix (Hepatitis A Vaccine)
    BLA Number: 103475
    351(a)
  • Havrix (Hepatitis A Vaccine)
    BLA Number: 103475
    351(a)
  • Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant))
    BLA Number: 103332
    351(a)
  • Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant))
    BLA Number: 103332
    351(a)
  • Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant))
    BLA Number: 103332
    351(a)
  • Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant))
    BLA Number: 103332
    351(a)
  • Helixate Fs, Kogenate, Kogenate Fs (Antihemophilic Factor (Recombinant))
    BLA Number: 103332
    351(a)
  • Hemacord (Hematopoietic Progenitor Cells, Cord (HPC-C))
    BLA Number: 125397
    351(a)
  • Hemgenix (etranacogene dezaparvovec-drlb)
    BLA Number: 125772
    351(a)
  • Hemlibra (emicizumab-kxwh)
    BLA Number: 761083
    351(a)
  • Hemlibra (emicizumab-kxwh)
    BLA Number: 761083
    351(a)
  • Hemlibra (emicizumab-kxwh)
    BLA Number: 761083
    351(a)
  • Hemlibra (emicizumab-kxwh)
    BLA Number: 761083
    351(a)
  • Hemlibra (emicizumab-kxwh)
    BLA Number: 761083
    351(a)
  • Hemlibra (emicizumab-kxwh)
    BLA Number: 761083
    351(a)
  • Hemofil M (Antihemophilic Factor (Human))
    BLA Number: 101448
    351(a)
  • Hemofil M (Antihemophilic Factor (Human))
    BLA Number: 101448
    351(a)
  • Hemofil M (Antihemophilic Factor (Human))
    BLA Number: 101448
    351(a)
  • Hemofil M (Antihemophilic Factor (Human))
    BLA Number: 101448
    351(a)
  • Hepagam B (Hepatitis B Immune Globulin (Human))
    BLA Number: 125035
    351(a)
  • Hepagam B (Hepatitis B Immune Globulin (Human))
    BLA Number: 125035
    351(a)
  • Hepcludex (bulevirtide-gmod)
    BLA Number: 761468
    351(a)
  • Heplisav-B (Hepatitis B Vaccine (Recombinant), Adjuvanted)
    BLA Number: 125428
    351(a)
  • Herceptin (trastuzumab)
    BLA Number: 103792
    351(a)
  • Herceptin (trastuzumab)
    BLA Number: 103792
    351(a)
  • Herceptin Hylecta (trastuzumab and hyaluronidase-oysk)
    BLA Number: 761106
    351(a)
  • Hercessi (trastuzumab-strf)
    BLA Number: 761346
    351(k) Biosimilar
  • Hercessi (trastuzumab-strf)
    BLA Number: 761346
    351(k) Biosimilar
  • Herzuma (trastuzumab-pkrb)
    BLA Number: 761091
    351(k) Biosimilar
  • Herzuma (trastuzumab-pkrb)
    BLA Number: 761091
    351(k) Biosimilar
  • Hiberix (Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate))
    BLA Number: 125347
    351(a)
  • Histatrol (Positive Skin Test Control-Histamine)
    BLA Number: 103754
    351(a)
  • Histatrol (Positive Skin Test Control-Histamine)
    BLA Number: 103754
    351(a)
  • Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid)
    BLA Number: 125350
    351(a)
  • Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid)
    BLA Number: 125350
    351(a)
  • Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid)
    BLA Number: 125350
    351(a)
  • Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid)
    BLA Number: 125350
    351(a)
  • Hizentra (Immune Globulin Subcutaneous (Human), 20% Liquid)
    BLA Number: 125350
    351(a)
  • hudquzco rubber panel,rubber panel t.r.u.e. test (Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test)
    BLA Number: 125579
    351(a)
  • Hulio (adalimumab-fkjp)
    BLA Number: 761154
    351(k) Interchangeable
  • Hulio (adalimumab-fkjp)
    BLA Number: 761154
    351(k) Interchangeable
  • Hulio (adalimumab-fkjp)
    BLA Number: 761154
    351(k) Interchangeable
  • Humalog (insulin lispro)
    BLA Number: 020563
    351(a)
  • Humalog (insulin lispro)
    BLA Number: 205747
    351(a)
  • Humalog (insulin lispro)
    BLA Number: 020563
    351(a)
  • Humalog (insulin lispro)
    BLA Number: 205747
    351(a)
  • Humalog (insulin lispro)
    BLA Number: 020563
    351(a)
  • Humalog (insulin lispro)
    BLA Number: 020563
    351(a)
  • Humalog (insulin lispro)
    BLA Number: 020563
    351(a)
  • Humalog (insulin lispro)
    BLA Number: 020563
    351(a)
  • Humalog Mix 50/50 (insulin lispro protamine and insulin lispro)
    BLA Number: 021018
    351(a)
  • Humalog Mix 50/50 (insulin lispro protamine and insulin lispro)
    BLA Number: 021018
    351(a)
  • Humalog Mix 50/50 (insulin lispro protamine and insulin lispro)
    BLA Number: 021018
    351(a)
  • Humalog Mix 75/25 (insulin lispro protamine and insulin lispro)
    BLA Number: 021017
    351(a)
  • Humalog Mix 75/25 (insulin lispro protamine and insulin lispro)
    BLA Number: 021017
    351(a)
  • Humalog Mix 75/25 (insulin lispro protamine and insulin lispro)
    BLA Number: 021017
    351(a)
  • Human Albumin Grifols (Albumin (Human))
    BLA Number: 103352
    351(a)
  • Human Albumin Grifols (Albumin (Human))
    BLA Number: 103352
    351(a)
  • Human Albumin Grifols (Albumin (Human))
    BLA Number: 103352
    351(a)
  • Human Albumin Grifols (Albumin (Human))
    BLA Number: 103352
    351(a)
  • Humate-P (Antihemophilic Factor/von Willebrand Factor Complex (Human))
    BLA Number: 103960
    351(a)
  • Humate-P (Antihemophilic Factor/von Willebrand Factor Complex (Human))
    BLA Number: 103960
    351(a)
  • Humate-P (Antihemophilic Factor/von Willebrand Factor Complex (Human))
    BLA Number: 103960
    351(a)
  • Humatrope (somatropin)
    BLA Number: 019640
    351(a)
  • Humatrope (somatropin)
    BLA Number: 019640
    351(a)
  • Humatrope (somatropin)
    BLA Number: 019640
    351(a)
  • Humatrope (somatropin)
    BLA Number: 019640
    351(a)
  • Humatrope (somatropin)
    BLA Number: 019640
    351(a)
  • Humegon (menotropins)
    BLA Number: 020328
    351(a)
  • Humegon (menotropins)
    BLA Number: 020328
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humira (adalimumab)
    BLA Number: 125057
    351(a)
  • Humulin 70/30 (insulin isophane human and insulin human)
    BLA Number: 019717
    351(a)
  • Humulin 70/30 (insulin isophane human and insulin human)
    BLA Number: 019717
    351(a)
  • Humulin 70/30 (insulin isophane human and insulin human)
    BLA Number: 019717
    351(a)
  • Humulin N (insulin isophane human)
    BLA Number: 018781
    351(a)
  • Humulin N (insulin isophane human)
    BLA Number: 018781
    351(a)
  • Humulin N (insulin isophane human)
    BLA Number: 018781
    351(a)
  • Humulin R U-100 (insulin human)
    BLA Number: 018780
    351(a)
  • Humulin R U-100 (insulin human)
    BLA Number: 018780
    351(a)
  • Humulin R U-100 (insulin human)
    BLA Number: 018780
    351(a)
  • Humulin R U-500 (insulin human)
    BLA Number: 018780
    351(a)
  • Humulin R U-500 (insulin human)
    BLA Number: 018780
    351(a)
  • Hydase (hyaluronidase)
    BLA Number: 021716
    351(a)
  • Hylenex recombinant (hyaluronidase human)
    BLA Number: 021859
    351(a)
  • Hympavzi (marstacimab-hncq)
    BLA Number: 761369
    351(a)
  • Hympavzi (marstacimab-hncq)
    BLA Number: 761369
    351(a)
  • Hympavzi (marstacimab-hncq)
    BLA Number: 761369
    351(a)
  • Hympavzi (marstacimab-hncq)
    BLA Number: 761369
    351(a)
  • Hyqvia (Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase)
    BLA Number: 125402
    351(a)
  • Hyrimoz (adalimumab-adaz)
    BLA Number: 761071
    351(k) Interchangeable
  • Hyrimoz (adalimumab-adaz)
    BLA Number: 761071
    351(k) Interchangeable
  • Hyrimoz (adalimumab-adaz)
    BLA Number: 761071
    351(k) Interchangeable
  • Hyrimoz (adalimumab-adaz)
    BLA Number: 761071
    351(k) Interchangeable
  • Hyrimoz (adalimumab-adaz)
    BLA Number: 761071
    351(k) Interchangeable
  • Hyrimoz (adalimumab-adaz)
    BLA Number: 761071
    351(k) Interchangeable
  • Hyrimoz (adalimumab-adaz)
    BLA Number: 761071
    351(k) Interchangeable
  • Hyrimoz (adalimumab-adaz)
    BLA Number: 761071
    351(k) Interchangeable
  • Hyrimoz (adalimumab-adaz)
    BLA Number: 761071
    351(k) Interchangeable
  • Hyrimoz (adalimumab-adaz)
    BLA Number: 761071
    351(k) Interchangeable
  • Idacio (adalimumab-aacf)
    BLA Number: 761255
    351(k) Biosimilar
  • Idacio (adalimumab-aacf)
    BLA Number: 761255
    351(k) Biosimilar
  • Idacio (adalimumab-aacf)
    BLA Number: 761255
    351(k) Biosimilar
  • Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)
    BLA Number: 125582
    351(a)
  • Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)
    BLA Number: 125582
    351(a)
  • Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)
    BLA Number: 125582
    351(a)
  • Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)
    BLA Number: 125582
    351(a)
  • Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein)
    BLA Number: 125582
    351(a)
  • Ilaris (canakinumab)
    BLA Number: 125319
    351(a)
  • Ilaris (canakinumab)
    BLA Number: 125319
    351(a)
  • Ilumya (tildrakizumab-asmn)
    BLA Number: 761067
    351(a)
  • Imaavy (nipocalimab-aahu)
    BLA Number: 761430
    351(a)
  • Imaavy (nipocalimab-aahu)
    BLA Number: 761430
    351(a)
  • Imdelltra (tarlatamab-dlle)
    BLA Number: 761344
    351(a)
  • Imdelltra (tarlatamab-dlle)
    BLA Number: 761344
    351(a)
  • Imfinzi (durvalumab)
    BLA Number: 761069
    351(a)
  • Imfinzi (durvalumab)
    BLA Number: 761069
    351(a)
  • Imjudo (tremelimumab-actl)
    BLA Number: 761289
    351(a)
  • Imjudo (tremelimumab-actl)
    BLA Number: 761289
    351(a)
  • Imlygic (Talimogene laherparepvec)
    BLA Number: 125518
    351(a)
  • Imlygic (Talimogene laherparepvec)
    BLA Number: 125518
    351(a)
  • Imogam (Rabies Immune Globulin (Human))
    BLA Number: 103932
    351(a)
  • Imovax Rabies (Rabies Vaccine)
    BLA Number: 103931
    351(a)
  • Imuldosa (ustekinumab-srlf)
    BLA Number: 761364
    351(k) Interchangeable
  • Imuldosa (ustekinumab-srlf)
    BLA Number: 761364
    351(k) Interchangeable
  • Imuldosa (ustekinumab-srlf)
    BLA Number: 761364
    351(k) Interchangeable
  • Increlex (mecasermin)
    BLA Number: 021839
    351(a)
  • Infanrix (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed)
    BLA Number: 103647
    351(a)
  • Infanrix (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed)
    BLA Number: 103647
    351(a)
  • Infasurf (calfactant)
    BLA Number: 020521
    351(a)
  • Infasurf (calfactant)
    BLA Number: 020521
    351(a)
  • Infergen (interferon alfacon-1)
    BLA Number: 103663
    351(a)
  • Inflectra (infliximab-dyyb)
    BLA Number: 125544
    351(k) Biosimilar
  • Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn)
    BLA Number: 761169
    351(a)
  • Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn)
    BLA Number: 761169
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Intron A (interferon alfa-2b)
    BLA Number: 103132
    351(a)
  • Iplex (mecasermin rinfabate)
    BLA Number: 021884
    351(a)
  • Ipol (Poliovirus Vaccine Inactivated)
    BLA Number: 103930
    351(a)
  • Ipol (Poliovirus Vaccine Inactivated)
    BLA Number: 103930
    351(a)
  • Iprivask (desirudin)
    BLA Number: 021271
    351(a)
  • ITVISMA (onasemnogene abeparvovec-brve)
    BLA Number: 125856
    351(a)
  • IXCHIQ (Chikungunya Vaccine, Live)
    BLA Number: 125777
    351(a)
  • Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed)
    BLA Number: 125280
    351(a)
  • Ixifi (infliximab-qbtx)
    BLA Number: 761072
    351(k) Biosimilar
  • Ixinity (Coagulation Factor IX (Recombinant))
    BLA Number: 125426
    351(a)
  • Ixinity (Coagulation Factor IX (Recombinant))
    BLA Number: 125426
    351(a)
  • Ixinity (Coagulation Factor IX (Recombinant))
    BLA Number: 125426
    351(a)
  • Ixinity (Coagulation Factor IX (Recombinant))
    BLA Number: 125426
    351(a)
  • Ixinity (Coagulation Factor IX (Recombinant))
    BLA Number: 125426
    351(a)
  • Ixinity (Coagulation Factor IX (Recombinant))
    BLA Number: 125426
    351(a)
  • Jeanatope (iodinated I-125 albumin)
    BLA Number: 017836
    351(a)
  • Jeanatope (iodinated I-125 albumin)
    BLA Number: 017836
    351(a)
  • Jeanatope (iodinated I-125 albumin)
    BLA Number: 017836
    351(a)
  • Jemperli (dostarlimab-gxly)
    BLA Number: 761174
    351(a)
  • Jetrea (ocriplasmin)
    BLA Number: 125422
    351(a)
  • Jetrea (ocriplasmin)
    BLA Number: 125422
    351(a)
  • Jeuveau (prabotulinumtoxinA-xvfs)
    BLA Number: 761085
    351(a)
  • Jivi (Antihemophilic factor (recombinant), PEGylated-aucl)
    BLA Number: 125661
    351(a)
  • Jivi (Antihemophilic factor (recombinant), PEGylated-aucl)
    BLA Number: 125661
    351(a)
  • Jivi (Antihemophilic factor (recombinant), PEGylated-aucl)
    BLA Number: 125661
    351(a)
  • Jivi (Antihemophilic factor (recombinant), PEGylated-aucl)
    BLA Number: 125661
    351(a)
  • Jivi (Antihemophilic factor (recombinant), PEGylated-aucl)
    BLA Number: 125661
    351(a)
  • Jobevne (bevacizumab-nwgd)
    BLA Number: 761175
    351(k) Biosimilar
  • Jobevne (bevacizumab-nwgd)
    BLA Number: 761175
    351(k) Biosimilar
  • Jubbonti (denosumab-bbdz)
    BLA Number: 761362
    351(k) Interchangeable
  • Jubereq (denosumab-desu)
    BLA Number: 761424
    351(k) Interchangeable
  • Jynneos (Smallpox and Mpox Vaccine, Live, Non-replicating)
    BLA Number: 125678
    351(a)
  • Jynneos (Smallpox and Mpox Vaccine, Live, Non-replicating)
    BLA Number: 125678
    351(a)
  • Kadcyla (ado-trastuzumab emtansine)
    BLA Number: 125427
    351(a)
  • Kadcyla (ado-trastuzumab emtansine)
    BLA Number: 125427
    351(a)
  • Kalbitor (ecallantide)
    BLA Number: 125277
    351(a)
  • Kanjinti (trastuzumab-anns)
    BLA Number: 761073
    351(k) Biosimilar
  • Kanjinti (trastuzumab-anns)
    BLA Number: 761073
    351(k) Biosimilar
  • Kanuma (sebelipase alfa)
    BLA Number: 125561
    351(a)
  • Kcentra (Prothrombin Complex Concentrate (Human))
    BLA Number: 125421
    351(a)
  • Kcentra (Prothrombin Complex Concentrate (Human))
    BLA Number: 125421
    351(a)
  • KEBILIDI (eladocagene exuparvovec-tneq)
    BLA Number: 125722
    351(a)
  • Kedbumin (Albumin (Human))
    BLA Number: 125384
    351(a)
  • Kedbumin (Albumin (Human))
    BLA Number: 125384
    351(a)
  • Kedrab (Rabies Immune Globulin (Human))
    BLA Number: 125613
    351(a)
  • Kepivance (palifermin)
    BLA Number: 125103
    351(a)
  • Kesimpta (ofatumumab)
    BLA Number: 125326
    351(a)
  • Kesimpta (ofatumumab)
    BLA Number: 125326
    351(a)
  • Kevzara (sarilumab)
    BLA Number: 761037
    351(a)
  • Kevzara (sarilumab)
    BLA Number: 761037
    351(a)
  • Kevzara (sarilumab)
    BLA Number: 761037
    351(a)
  • Kevzara (sarilumab)
    BLA Number: 761037
    351(a)
  • Keytruda (pembrolizumab)
    BLA Number: 125514
    351(a)
  • Keytruda (pembrolizumab)
    BLA Number: 125514
    351(a)
  • Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)
    BLA Number: 761467
    351(a)
  • Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph)
    BLA Number: 761467
    351(a)
  • Kimmtrak (tebentafusp-tebn)
    BLA Number: 761228
    351(a)
  • Kineret (anakinra)
    BLA Number: 103950
    351(a)
  • Kinlytic (urokinase)
    BLA Number: 021846
    351(a)
  • Kinlytic (urokinase)
    BLA Number: 021846
    351(a)
  • Kinlytic (urokinase)
    BLA Number: 021846
    351(a)
  • Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
    BLA Number: 125260
    351(a)
  • Kirsty (insulin aspart-xjhz)
    BLA Number: 761188
    351(k) Interchangeable
  • Kirsty (insulin aspart-xjhz)
    BLA Number: 761188
    351(k) Interchangeable
  • Kisunla (donanemab-azbt)
    BLA Number: 761248
    351(a)
  • Koate, Koate-Dvi (Antihemophilic Factor (Human))
    BLA Number: 101130
    351(a)
  • Koate, Koate-Dvi (Antihemophilic Factor (Human))
    BLA Number: 101130
    351(a)
  • Koate, Koate-Dvi (Antihemophilic Factor (Human))
    BLA Number: 101130
    351(a)
  • Kovaltry (Antihemophilic Factor (Recombinant), Full Length)
    BLA Number: 125574
    351(a)
  • Kovaltry (Antihemophilic Factor (Recombinant), Full Length)
    BLA Number: 125574
    351(a)
  • Kovaltry (Antihemophilic Factor (Recombinant), Full Length)
    BLA Number: 125574
    351(a)
  • Kovaltry (Antihemophilic Factor (Recombinant), Full Length)
    BLA Number: 125574
    351(a)
  • Kovaltry (Antihemophilic Factor (Recombinant), Full Length)
    BLA Number: 125574
    351(a)
  • kresladi (marnetegragene autotemcel)
    BLA Number: 125806
    351(a)
  • Krystexxa (pegloticase)
    BLA Number: 125293
    351(a)
  • Krystexxa (pegloticase)
    BLA Number: 125293
    351(a)
  • Kymriah (tisagenlecleucel)
    BLA Number: 125646
    351(a)
  • Lamzede (velmanase alfa-tycv)
    BLA Number: 761278
    351(a)
  • Langlara (insulin glargine-aldy)
    BLA Number: 761412
    351(k) Interchangeable
  • Lantidra (donislecel-jujn)
    BLA Number: 125734
    351(a)
  • Lantus (insulin glargine)
    BLA Number: 021081
    351(a)
  • Lantus (insulin glargine)
    BLA Number: 021081
    351(a)
  • Lantus (insulin glargine)
    BLA Number: 021081
    351(a)
  • Lantus (insulin glargine)
    BLA Number: 021081
    351(a)
  • Lartruvo (olaratumab)
    BLA Number: 761038
    351(a)
  • Lartruvo (olaratumab)
    BLA Number: 761038
    351(a)
  • Laviv (Azficel-T)
    BLA Number: 125348
    351(a)
  • Lemtrada (alemtuzumab)
    BLA Number: 103948
    351(a)
  • Lenmeldy (atidarsagene autotemcel)
    BLA Number: 125758
    351(a)
  • Leqembi (lecanemab-irmb)
    BLA Number: 761269
    351(a)
  • Leqembi (lecanemab-irmb)
    BLA Number: 761269
    351(a)
  • Leqembi IQLIK (lecanemab-irmb)
    BLA Number: 761375
    351(a)
  • Lerochol (lerodalcibep-liga)
    BLA Number: 761427
    351(a)
  • Letybo (letibotulinumtoxinA-wlbg)
    BLA Number: 761225
    351(a)
  • Letybo (letibotulinumtoxinA-wlbg)
    BLA Number: 761225
    351(a)
  • Leukine (sargramostim)
    BLA Number: 103362
    351(a)
  • Leukine (sargramostim)
    BLA Number: 103362
    351(a)
  • Levemir (insulin detemir)
    BLA Number: 021536
    351(a)
  • Levemir (insulin detemir)
    BLA Number: 021536
    351(a)
  • Levemir (insulin detemir)
    BLA Number: 021536
    351(a)
  • Levemir (insulin detemir)
    BLA Number: 021536
    351(a)
  • Levemir (insulin detemir)
    BLA Number: 021536
    351(a)
  • Libtayo (cemiplimab-rwlc)
    BLA Number: 761097
    351(a)
  • Loargys (pegzilarginase-nbln)
    BLA Number: 761211
    351(a)
  • Loargys (pegzilarginase-nbln)
    BLA Number: 761211
    351(a)
  • Loqtorzi (toripalimab-tpzi)
    BLA Number: 761240
    351(a)
  • Lucentis (ranibizumab)
    BLA Number: 125156
    351(a)
  • Lucentis (ranibizumab)
    BLA Number: 125156
    351(a)
  • Lucentis (ranibizumab)
    BLA Number: 125156
    351(a)
  • Lucentis (ranibizumab)
    BLA Number: 125156
    351(a)
  • Lumizyme (alglucosidase alfa)
    BLA Number: 125291
    351(a)
  • Lumoxiti (moxetumomab pasudotox-tdfk)
    BLA Number: 761104
    351(a)
  • Lunsumio (mosunetuzumab-axgb)
    BLA Number: 761263
    351(a)
  • Lunsumio (mosunetuzumab-axgb)
    BLA Number: 761263
    351(a)
  • Lunsumio Velo (mosunetuzumab-axgb)
    BLA Number: 761263
    351(a)
  • Lunsumio Velo (mosunetuzumab-axgb)
    BLA Number: 761263
    351(a)
  • Luxturna (Voretigene Neparvovec)
    BLA Number: 125610
    351(a)
  • LYFGENIA (lovotibeglogene autotemcel)
    BLA Number: 125788
    351(a)
  • Lymphir (denileukin diftitox-cxdl)
    BLA Number: 761312
    351(a)
  • Lynozyfic (linvoseltamab-gcpt)
    BLA Number: 761400
    351(a)
  • Lynozyfic (linvoseltamab-gcpt)
    BLA Number: 761400
    351(a)
  • Lyumjev (insulin lispro-aabc)
    BLA Number: 761109
    351(a)
  • Lyumjev (insulin lispro-aabc)
    BLA Number: 761109
    351(a)
  • Lyumjev (insulin lispro-aabc)
    BLA Number: 761109
    351(a)
  • Lyumjev (insulin lispro-aabc)
    BLA Number: 761109
    351(a)
  • Lyumjev (insulin lispro-aabc)
    BLA Number: 761109
    351(a)
  • Lyumjev (insulin lispro-aabc)
    BLA Number: 761109
    351(a)
  • M-M-R Ii (Measles, Mumps and Rubella Virus Vaccine Live)
    BLA Number: 101069
    351(a)
  • M-M-R Ii (Measles, Mumps and Rubella Virus Vaccine Live)
    BLA Number: 101069
    351(a)
  • Maci (autologous cultured chondrocytes on porcine collagen membrane)
    BLA Number: 125603
    351(a)
  • Macrotec (kit for the preparation of technetium Tc-99m albumin aggregated)
    BLA Number: 017833
    351(a)
  • Margenza (margetuximab-cmkb)
    BLA Number: 761150
    351(a)
  • Megatope (iodinated I-131 albumin)
    BLA Number: 017837
    351(a)
  • Megatope (iodinated I-131 albumin)
    BLA Number: 017837
    351(a)
  • Megatope (iodinated I-131 albumin)
    BLA Number: 017837
    351(a)
  • Megatope (iodinated I-131 albumin)
    BLA Number: 017837
    351(a)
  • Megatope (iodinated I-131 albumin)
    BLA Number: 017837
    351(a)
  • Menactra (Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine)
    BLA Number: 125089
    351(a)
  • MENHIBRIX (Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine)
    BLA Number: 125363
    351(a)
  • Menomune (Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined)
    BLA Number: 103926
    351(a)
  • Menomune-A (Meningococcal Polysaccharide Vaccine, Group A)
    BLA Number: 103924
    351(a)
  • Menomune-A/C (Meningococcal Polysaccharide Vaccine, Groups A and C Combined)
    BLA Number: 103925
    351(a)
  • Menomune-A/C (Meningococcal Polysaccharide Vaccine, Groups A and C Combined)
    BLA Number: 103925
    351(a)
  • Menomune-C (Meningococcal Polysaccharide Vaccine, Group C)
    BLA Number: 103923
    351(a)
  • Menopur (menotropins)
    BLA Number: 021663
    351(a)
  • Menquadfi (Meningococcal (Groups A, C, Y, W) Conjugate Vaccine)
    BLA Number: 125701
    351(a)
  • Menveo (Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine)
    BLA Number: 125300
    351(a)
  • Menveo (Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine)
    BLA Number: 125300
    351(a)
  • Mepsevii (vestronidase alfa-vjbk)
    BLA Number: 761047
    351(a)
  • Merilog (insulin aspart-szjj)
    BLA Number: 761325
    351(k) Biosimilar
  • Merilog (insulin aspart-szjj)
    BLA Number: 761325
    351(k) Biosimilar
  • MERUVAX II (Rubella Virus Vaccine Live)
    BLA Number: 101075
    351(a)
  • Micrhogam, Rhogam (Rho(D) Immune Globulin (Human))
    BLA Number: 103777
    351(a)
  • Micrhogam, Rhogam (Rho(D) Immune Globulin (Human))
    BLA Number: 103777
    351(a)
  • Microlite (radiolabeled albumin technetium Tc-99m albumin colloid kit)
    BLA Number: 018263
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • Mircera (methoxy polyethylene glycol-epoetin beta)
    BLA Number: 125164
    351(a)
  • mnexspike (COVID-19 Vaccine, mRNA)
    BLA Number: 125835
    351(a)
  • Monjuvi (tafasitamab-cxix)
    BLA Number: 761163
    351(a)
  • Monoclate, Monoclate-P (Antihemophilic Factor (Human))
    BLA Number: 103953
    351(a)
  • Monoclate, Monoclate-P (Antihemophilic Factor (Human))
    BLA Number: 103953
    351(a)
  • Monoclate, Monoclate-P (Antihemophilic Factor (Human))
    BLA Number: 103953
    351(a)
  • Monoclate, Monoclate-P (Antihemophilic Factor (Human))
    BLA Number: 103953
    351(a)
  • Mononine (Coagulation Factor IX (Human))
    BLA Number: 103957
    351(a)
  • Mononine (Coagulation Factor IX (Human))
    BLA Number: 103957
    351(a)
  • mresvia (Respiratory Syncytial Virus Vaccine)
    BLA Number: 125796
    351(a)
  • MumpsVax (Mumps Virus Vaccine Live)
    BLA Number: 101072
    351(a)
  • Mvasi (bevacizumab-awwb)
    BLA Number: 761028
    351(k) Biosimilar
  • Mvasi (bevacizumab-awwb)
    BLA Number: 761028
    351(k) Biosimilar
  • Myalept (metreleptin)
    BLA Number: 125390
    351(a)
  • Mycobax (BCG Vaccine)
    BLA Number: 103942
    351(a)
  • Mylotarg (gemtuzumab ozogamicin)
    BLA Number: 761060
    351(a)
  • Myobloc (rimabotulinumtoxinB)
    BLA Number: 103846
    351(a)
  • Myobloc (rimabotulinumtoxinB)
    BLA Number: 103846
    351(a)
  • Myobloc (rimabotulinumtoxinB)
    BLA Number: 103846
    351(a)
  • Myozyme (alglucosidase alfa)
    BLA Number: 125141
    351(a)
  • Myxredlin (insulin human )
    BLA Number: 208157
    351(a)
  • N/A (raxibacumab)
    BLA Number: 125349
    351(a)
  • N/A (penpulimab-kcqx)
    BLA Number: 761258
    351(a)
  • N/A (Tetanus and Diphtheria Toxoids Adsorbed)
    BLA Number: 103921
    351(a)
  • N/A (Tetanus and Diphtheria Toxoids Adsorbed)
    BLA Number: 103921
    351(a)
  • N/A (Diphtheria & Tetanus Toxoids Adsorbed)
    BLA Number: 103919
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 103872
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 103872
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 103871
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 103871
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 103871
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 103870
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 103872
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 103871
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 103871
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 103870
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 103870
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 103870
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103810
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 103870
    351(a)
  • N/A (Animal Allergens, Standardized Cat Pelt)
    BLA Number: 103061
    351(a)
  • N/A (Animal Allergens, Standardized Cat Pelt)
    BLA Number: 103061
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 103060
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 103060
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 103059
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 103059
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 103058
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 103058
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 103057
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 103057
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 103056
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 103056
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 103055
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 103055
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 103055
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 103055
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 103054
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 103054
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 103054
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 103054
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 103053
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 101836
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 101836
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 101836
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 101836
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 101836
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 101836
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 101835
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 101835
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 101835
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 101835
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 101835
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 101835
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 101835
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 101834
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 101834
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 101834
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 101834
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 101834
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 101834
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 101834
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103810
    351(a)
  • N/A (Tetanus Toxoid Adsorbed)
    BLA Number: 103913
    351(a)
  • N/A (Adenovirus Type 4 and Type 7 Vaccine, Live, Oral)
    BLA Number: 125296
    351(a)
  • N/A (Antivenin (Crotalidae) Polyvalent)
    BLA Number: 101098
    351(a)
  • N/A (Influenza Virus Vaccine, H5N1)
    BLA Number: 125244
    351(a)
  • N/A (Venoms, White Faced Hornet Venom Protein)
    BLA Number: 103885
    351(a)
  • N/A (Venoms, Yellow Hornet Venom Protein)
    BLA Number: 103886
    351(a)
  • N/A (Venoms, Yellow Hornet Venom Protein)
    BLA Number: 103886
    351(a)
  • N/A (Venoms, Yellow Hornet Venom Protein)
    BLA Number: 103886
    351(a)
  • N/A (Venoms, Yellow Hornet Venom Protein)
    BLA Number: 103886
    351(a)
  • N/A (Venoms, White Faced Hornet Venom Protein)
    BLA Number: 103885
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 103052
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 103052
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 103053
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 103053
    351(a)
  • N/A (Positive Skin Test Control-Histamine)
    BLA Number: 103891
    351(a)
  • N/A (Venoms, Yellow Jacket Venom Protein)
    BLA Number: 103887
    351(a)
  • N/A (Venoms, Yellow Jacket Venom Protein)
    BLA Number: 103887
    351(a)
  • N/A (Venoms, Yellow Jacket Venom Protein)
    BLA Number: 103887
    351(a)
  • N/A (Venoms, Yellow Jacket Venom Protein)
    BLA Number: 103887
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 103752
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 103752
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103889
    351(a)
  • N/A (Animal Allergens, Standardized Cat Pelt)
    BLA Number: 103890
    351(a)
  • N/A (Animal Allergens, Standardized Cat Pelt)
    BLA Number: 103890
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103889
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103889
    351(a)
  • N/A (Animal Allergens, Standardized Cat Pelt)
    BLA Number: 103890
    351(a)
  • N/A (BCG Vaccine)
    BLA Number: 103050
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 103051
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 103051
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 103052
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 103052
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 103053
    351(a)
  • N/A (Albumin (Human))
    BLA Number: 125154
    351(a)
  • N/A (Albumin (Human))
    BLA Number: 125154
    351(a)
  • N/A (Albumin (Human))
    BLA Number: 125154
    351(a)
  • N/A (Albumin (Human))
    BLA Number: 125154
    351(a)
  • N/A (Albumin (Human))
    BLA Number: 125154
    351(a)
  • N/A (Albumin (Human))
    BLA Number: 125154
    351(a)
  • N/A (Albumin (Human))
    BLA Number: 125154
    351(a)
  • N/A (Venoms, Mixed Vespid Venom Protein)
    BLA Number: 103883
    351(a)
  • N/A (Venoms, Mixed Vespid Venom Protein)
    BLA Number: 103883
    351(a)
  • N/A (Venoms, Wasp Venom Protein)
    BLA Number: 103884
    351(a)
  • N/A (Venoms, Wasp Venom Protein)
    BLA Number: 103884
    351(a)
  • N/A (Venoms, Wasp Venom Protein)
    BLA Number: 103884
    351(a)
  • N/A (Venoms, Wasp Venom Protein)
    BLA Number: 103884
    351(a)
  • N/A (Venoms, White Faced Hornet Venom Protein)
    BLA Number: 103885
    351(a)
  • N/A (Venoms, White Faced Hornet Venom Protein)
    BLA Number: 103885
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 103879
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 103879
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 103880
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 103880
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 103880
    351(a)
  • N/A (Venoms, Honey Bee Venom)
    BLA Number: 103882
    351(a)
  • N/A (Venoms, Honey Bee Venom)
    BLA Number: 103882
    351(a)
  • N/A (Venoms, Honey Bee Venom)
    BLA Number: 103882
    351(a)
  • N/A (Venoms, Honey Bee Venom)
    BLA Number: 103882
    351(a)
  • N/A (Hematopoietic Progenitor Cells, Cord (HPC-C))
    BLA Number: 125657
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 101385
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 101386
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 101386
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 101386
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 101386
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 101387
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 101387
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 101387
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 102220
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 102220
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 102220
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 102220
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 102221
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 102221
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 102221
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 102221
    351(a)
  • N/A (Botulism Antitoxin Bivalent (Equine) Types A and B.)
    BLA Number: 103937
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 103879
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 103879
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 103879
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 103878
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 103878
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 103878
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 103879
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 103877
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 103877
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 103877
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 103877
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 103877
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 103878
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 103878
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 103878
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103324
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103324
    351(a)
  • N/A (Positive Skin Test Control-Histamine)
    BLA Number: 103317
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 102217
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 102217
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 102216
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 102216
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 102216
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 102215
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 102214
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 102214
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 102215
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 102215
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 102215
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 102216
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 102216
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 102216
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 102216
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 102216
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 102215
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 102215
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 102215
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 102215
    351(a)
  • N/A (Diphtheria & Tetanus Toxoids Adsorbed)
    BLA Number: 103944
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 103876
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 103876
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 101379
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 103876
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 102214
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 103874
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 101841
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 103877
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 103876
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 103876
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 103876
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 103875
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 103875
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 103875
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 103875
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 103875
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 103875
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 103874
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 103874
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 103874
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 103874
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 103873
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 103874
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 103873
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 103873
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 103873
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 103113
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 103113
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 102214
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 103872
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 102213
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 102213
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 102213
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 102213
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 102213
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 102213
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 102213
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 102213
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 102212
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 102212
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 102212
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 103873
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 103873
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 101840
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 101840
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 101840
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 101840
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
    BLA Number: 101845
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
    BLA Number: 101845
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 101840
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 101840
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 102212
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 102212
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 102212
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 102212
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 102212
    351(a)
  • N/A (Albumin (Human))
    BLA Number: 101993
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
    BLA Number: 101845
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
    BLA Number: 101845
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
    BLA Number: 101845
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 101839
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 101839
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 101839
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 101839
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 101839
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 101839
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 101838
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 101838
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 101838
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 101838
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 101838
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 101838
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 101837
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 101837
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 101837
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 101378
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides pteronyssinus)
    BLA Number: 101378
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 101377
    351(a)
  • N/A (Insects (Whole Body), Mite Dermatophagoides farinae)
    BLA Number: 101377
    351(a)
  • N/A (HPC, Cord Blood)
    BLA Number: 125585
    351(a)
  • N/A (HPC, Cord Blood)
    BLA Number: 125391
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 101385
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 101385
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 101384
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 102217
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 101841
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 101841
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 101841
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 101841
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 101841
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 101842
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 101842
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 101842
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 101842
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 101384
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 101383
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 101384
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 101384
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 101383
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 101382
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 101382
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 101383
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 101383
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 101382
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 101381
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 101382
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 101381
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 101381
    351(a)
  • N/A (Pollens - Grasses, Fescue, Meadow Festuca elatior)
    BLA Number: 101381
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 101380
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 101380
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 101380
    351(a)
  • N/A (Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis)
    BLA Number: 101380
    351(a)
  • N/A (Pollens - Grasses, Bermuda Grass Cynodon dactylon)
    BLA Number: 101379
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 101385
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 102220
    351(a)
  • N/A (Plague Vaccine)
    BLA Number: 103569
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 102220
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 102220
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103397
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103397
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103397
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103473
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103473
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103397
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103397
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103397
    351(a)
  • N/A (Animal Allergens, Standardized Cat Hair)
    BLA Number: 103397
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 101842
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 101842
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 101843
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 101843
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 101843
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 101843
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 101843
    351(a)
  • N/A (Pollens - Grasses, Timothy Phleum pratense)
    BLA Number: 101843
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 101844
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 101844
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia artemisiifolia)
    BLA Number: 101844
    351(a)
  • N/A (Pollens - Weeds and Garden Plants, Ragweed, Short Ambrosia elatior)
    BLA Number: 101845
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 102217
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 102217
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 102217
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 102217
    351(a)
  • N/A (Pollens - Grasses, Orchard Grass Dactylis glomerata)
    BLA Number: 102217
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 102218
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 102218
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 102218
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 102218
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 102218
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 102218
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 102218
    351(a)
  • N/A (Pollens - Grasses, Redtop Agrostis alba)
    BLA Number: 102218
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 102219
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 102219
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 102219
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 102219
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 102219
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 102219
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 102219
    351(a)
  • N/A (Pollens - Grasses, Ryegrass, Perennial Lolium perenne)
    BLA Number: 102219
    351(a)
  • N/A (Pollens - Grasses, Sweet Vernal Grass Anthoxanthum odoratum)
    BLA Number: 102220
    351(a)
  • Nabi-HB (Hepatitis B Immune Globulin (Human))
    BLA Number: 103945
    351(a)
  • Nabi-HB (Hepatitis B Immune Globulin (Human))
    BLA Number: 103945
    351(a)
  • Naglazyme (galsulfase )
    BLA Number: 125117
    351(a)
  • Natpara (parathyroid hormone)
    BLA Number: 125511
    351(a)
  • Natpara (parathyroid hormone)
    BLA Number: 125511
    351(a)
  • Natpara (parathyroid hormone)
    BLA Number: 125511
    351(a)
  • Natpara (parathyroid hormone)
    BLA Number: 125511
    351(a)
  • Nemluvio (nemolizumab-ilto)
    BLA Number: 761390
    351(a)
  • Neulasta (pegfilgrastim)
    BLA Number: 125031
    351(a)
  • Neulasta Onpro (pegfilgrastim)
    BLA Number: 125031
    351(a)
  • Neumega (oprelvekin)
    BLA Number: 103694
    351(a)
  • Neupogen (filgrastim)
    BLA Number: 103353
    351(a)
  • Neupogen (filgrastim)
    BLA Number: 103353
    351(a)
  • Neupogen (filgrastim)
    BLA Number: 103353
    351(a)
  • Neupogen (filgrastim)
    BLA Number: 103353
    351(a)
  • NeutroSpec (technetium 99m tc fanolesomab)
    BLA Number: 103928
    351(a)
  • Nexobrid (anacaulase-bcdb)
    BLA Number: 761192
    351(a)
  • Nexobrid (anacaulase-bcdb)
    BLA Number: 761192
    351(a)
  • Nexviazyme (avalglucosidase alfa-ngpt)
    BLA Number: 761194
    351(a)
  • Ngenla (somatrogon-ghla)
    BLA Number: 761184
    351(a)
  • Ngenla (somatrogon-ghla)
    BLA Number: 761184
    351(a)
  • Niktimvo (axatilimab-csfr)
    BLA Number: 761411
    351(a)
  • Nivestym (filgrastim-aafi)
    BLA Number: 761080
    351(k) Biosimilar
  • Nivestym (filgrastim-aafi)
    BLA Number: 761080
    351(k) Biosimilar
  • Nivestym (filgrastim-aafi)
    BLA Number: 761080
    351(k) Biosimilar
  • Nivestym (filgrastim-aafi)
    BLA Number: 761080
    351(k) Biosimilar
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Norditropin (somatropin)
    BLA Number: 021148
    351(a)
  • Novarel (chorionic gonadotropin)
    BLA Number: 017016
    351(a)
  • Novarel (chorionic gonadotropin)
    BLA Number: 017016
    351(a)
  • Novarel (chorionic gonadotropin)
    BLA Number: 017016
    351(a)
  • Novarel (chorionic gonadotropin)
    BLA Number: 017016
    351(a)
  • Novarel (chorionic gonadotropin)
    BLA Number: 017016
    351(a)
  • Novarel (chorionic gonadotropin)
    BLA Number: 017016
    351(a)
  • Novoeight (Antihemophilic Factor (Recombinant))
    BLA Number: 125466
    351(a)
  • Novoeight (Antihemophilic Factor (Recombinant))
    BLA Number: 125466
    351(a)
  • Novoeight (Antihemophilic Factor (Recombinant))
    BLA Number: 125466
    351(a)
  • Novoeight (Antihemophilic Factor (Recombinant))
    BLA Number: 125466
    351(a)
  • Novoeight (Antihemophilic Factor (Recombinant))
    BLA Number: 125466
    351(a)
  • Novoeight (Antihemophilic Factor (Recombinant))
    BLA Number: 125466
    351(a)
  • Novolin 70/30 (insulin isophane human and insulin human)
    BLA Number: 019991
    351(a)
  • Novolin 70/30 (insulin isophane human and insulin human)
    BLA Number: 019991
    351(a)
  • Novolin N (insulin isophane human)
    BLA Number: 019959
    351(a)
  • Novolin N (insulin isophane human)
    BLA Number: 019959
    351(a)
  • Novolin R (insulin human)
    BLA Number: 019938
    351(a)
  • Novolin R (insulin human)
    BLA Number: 019938
    351(a)
  • Novolog (insulin aspart)
    BLA Number: 020986
    351(a)
  • Novolog (insulin aspart)
    BLA Number: 020986
    351(a)
  • Novolog (insulin aspart)
    BLA Number: 020986
    351(a)
  • Novolog (insulin aspart)
    BLA Number: 020986
    351(a)
  • Novolog (insulin aspart)
    BLA Number: 020986
    351(a)
  • Novolog Mix 50/50 (insulin aspart protamine and insulin aspart)
    BLA Number: 021810
    351(a)
  • Novolog Mix 50/50 (insulin aspart protamine and insulin aspart)
    BLA Number: 021810
    351(a)
  • Novolog Mix 70/30 (insulin aspart protamine and insulin aspart)
    BLA Number: 021172
    351(a)
  • Novolog Mix 70/30 (insulin aspart protamine and insulin aspart)
    BLA Number: 021172
    351(a)
  • Novolog Mix 70/30 (insulin aspart protamine and insulin aspart)
    BLA Number: 021172
    351(a)
  • Novolog Mix 70/30 (insulin aspart protamine and insulin aspart)
    BLA Number: 021172
    351(a)
  • Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
    BLA Number: 103665
    351(a)
  • Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
    BLA Number: 103665
    351(a)
  • Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
    BLA Number: 103665
    351(a)
  • Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
    BLA Number: 103665
    351(a)
  • Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
    BLA Number: 103665
    351(a)
  • Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
    BLA Number: 103665
    351(a)
  • Novoseven, Novoseven Rt (Coagulation Factor VIIa (Recombinant))
    BLA Number: 103665
    351(a)
  • Nplate (romiplostim)
    BLA Number: 125268
    351(a)
  • Nplate (romiplostim)
    BLA Number: 125268
    351(a)
  • Nplate (romiplostim)
    BLA Number: 125268
    351(a)
  • Nucala (mepolizumab)
    BLA Number: 125526
    351(a)
  • Nucala (mepolizumab)
    BLA Number: 125526
    351(a)
  • Nucala (mepolizumab)
    BLA Number: 125526
    351(a)
  • Nucala (mepolizumab)
    BLA Number: 125526
    351(a)
  • Nucala (mepolizumab)
    BLA Number: 761122
    351(a)
  • Nucala (mepolizumab)
    BLA Number: 761122
    351(a)
  • Nucala (mepolizumab)
    BLA Number: 761122
    351(a)
  • Nucala (mepolizumab)
    BLA Number: 761122
    351(a)
  • Nufymco (ranibizumab-leyk)
    BLA Number: 761473
    351(k) Interchangeable
  • Nufymco (ranibizumab-leyk)
    BLA Number: 761473
    351(k) Interchangeable
  • Nulojix (belatacept)
    BLA Number: 125288
    351(a)
  • Nutropin (somatropin)
    BLA Number: 020168
    351(a)
  • Nutropin (somatropin)
    BLA Number: 020168
    351(a)
  • Nutropin AQ (somatropin)
    BLA Number: 020522
    351(a)
  • Nutropin AQ (somatropin)
    BLA Number: 020522
    351(a)
  • Nutropin AQ (somatropin)
    BLA Number: 020522
    351(a)
  • Nutropin AQ (somatropin)
    BLA Number: 020522
    351(a)
  • Nutropin AQ (somatropin)
    BLA Number: 020522
    351(a)
  • Nutropin AQ (somatropin)
    BLA Number: 020522
    351(a)
  • NUVAXOVID (COVID-19 Vaccine, Adjuvanted)
    BLA Number: 125817
    351(a)
  • Nuwiq (Antihemophilic Factor (Recombinant))
    BLA Number: 125555
    351(a)
  • Nuwiq (Antihemophilic Factor (Recombinant))
    BLA Number: 125555
    351(a)
  • Nuwiq (Antihemophilic Factor (Recombinant))
    BLA Number: 125555
    351(a)
  • Nuwiq (Antihemophilic Factor (Recombinant))
    BLA Number: 125555
    351(a)
  • Nuwiq (Antihemophilic Factor (Recombinant))
    BLA Number: 125555
    351(a)
  • Nuwiq (Antihemophilic Factor (Recombinant))
    BLA Number: 125555
    351(a)
  • Nuwiq (Antihemophilic Factor (Recombinant))
    BLA Number: 125555
    351(a)
  • Nuwiq (Antihemophilic Factor (Recombinant))
    BLA Number: 125555
    351(a)
  • Nypozi (filgrastim-txid)
    BLA Number: 761126
    351(k) Biosimilar
  • Nypozi (filgrastim-txid)
    BLA Number: 761126
    351(k) Biosimilar
  • Nyvepria (pegfilgrastim-apgf)
    BLA Number: 761111
    351(k) Biosimilar
  • Obizur (Antihemophilic Factor (Recombinant), Porcine Sequence)
    BLA Number: 125512
    351(a)
  • Ocrevus (ocrelizumab)
    BLA Number: 761053
    351(a)
  • Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)
    BLA Number: 761371
    351(a)
  • Octagam (Immune Globulin Intravenous (Human))
    BLA Number: 125062
    351(a)
  • Octagam (Immune Globulin Intravenous (Human))
    BLA Number: 125062
    351(a)
  • Octagam (Immune Globulin Intravenous (Human))
    BLA Number: 125062
    351(a)
  • Octagam (Immune Globulin Intravenous (Human))
    BLA Number: 125062
    351(a)
  • Octagam (Immune Globulin Intravenous (Human))
    BLA Number: 125062
    351(a)
  • Octagam (Immune Globulin Intravenous (Human))
    BLA Number: 125062
    351(a)
  • Octagam (Immune Globulin Intravenous (Human))
    BLA Number: 125062
    351(a)
  • Octagam (Immune Globulin Intravenous (Human))
    BLA Number: 125062
    351(a)
  • Octagam (Immune Globulin Intravenous (Human))
    BLA Number: 125062
    351(a)
  • Octaplas (Pooled Plasma (Human), Solvent/Detergent Treated)
    BLA Number: 125416
    351(a)
  • Odactra (House Dust Mites (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract)
    BLA Number: 125592
    351(a)
  • Ogivri (trastuzumab-dkst)
    BLA Number: 761074
    351(k) Biosimilar
  • Ogivri (trastuzumab-dkst)
    BLA Number: 761074
    351(k) Biosimilar
  • OMISIRGE (omidubicel-onlv)
    BLA Number: 125738
    351(a)
  • Omlyclo (omalizumab-igec)
    BLA Number: 761399
    351(k) Interchangeable
  • Omlyclo (omalizumab-igec)
    BLA Number: 761399
    351(k) Interchangeable
  • Omlyclo (omalizumab-igec)
    BLA Number: 761399
    351(k) Interchangeable
  • Omnitrope (somatropin)
    BLA Number: 021426
    351(a)
  • Omnitrope (somatropin)
    BLA Number: 021426
    351(a)
  • Omnitrope (somatropin)
    BLA Number: 021426
    351(a)
  • Omnitrope (somatropin)
    BLA Number: 021426
    351(a)
  • Omvoh (mirikizumab-mrkz)
    BLA Number: 761279
    351(a)
  • Omvoh (mirikizumab-mrkz)
    BLA Number: 761279
    351(a)
  • Omvoh (mirikizumab-mrkz)
    BLA Number: 761279
    351(a)
  • Omvoh (mirikizumab-mrkz)
    BLA Number: 761279
    351(a)
  • Omvoh (mirikizumab-mrkz)
    BLA Number: 761279
    351(a)
  • Oncaspar (pegaspargase)
    BLA Number: 103411
    351(a)
  • Ontak (denileukin diftitox)
    BLA Number: 103767
    351(a)
  • Ontruzant (trastuzumab-dttb)
    BLA Number: 761100
    351(k) Biosimilar
  • Ontruzant (trastuzumab-dttb)
    BLA Number: 761100
    351(k) Biosimilar
  • Opdivo (nivolumab)
    BLA Number: 125554
    351(a)
  • Opdivo (nivolumab)
    BLA Number: 125554
    351(a)
  • Opdivo (nivolumab)
    BLA Number: 125554
    351(a)
  • Opdivo (nivolumab)
    BLA Number: 125554
    351(a)
  • Opdivo Qvantig (nivolumab and hyaluronidase-nvhy)
    BLA Number: 761381
    351(a)
  • Opdivo Qvantig (nivolumab and hyaluronidase-nvhy)
    BLA Number: 761381
    351(a)
  • Opdualag (nivolumab and relatlimab-rmbw)
    BLA Number: 761234
    351(a)
  • Opuviz (aflibercept-yszy)
    BLA Number: 761350
    351(k) Interchangeable
  • Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract)
    BLA Number: 125471
    351(a)
  • Orencia (abatacept)
    BLA Number: 125118
    351(a)
  • Orencia (abatacept)
    BLA Number: 125118
    351(a)
  • Orencia (abatacept)
    BLA Number: 125118
    351(a)
  • Orencia (abatacept)
    BLA Number: 125118
    351(a)
  • Orencia (abatacept)
    BLA Number: 125118
    351(a)
  • Orthoclone OKT3 (muromonab-CD3)
    BLA Number: 103463
    351(a)
  • Osenvelt (denosumab-bmwo)
    BLA Number: 761404
    351(k) Interchangeable
  • Ospomyv (denosumab-dssb)
    BLA Number: 761392
    351(k) Interchangeable
  • Osvyrti (denosumab-desu)
    BLA Number: 761424
    351(k) Interchangeable
  • OTARMENI (lunsotogene parvec-cwha)
    BLA Number: 125874
    351(a)
  • Otulfi (ustekinumab-aauz)
    BLA Number: 761379
    351(k) Interchangeable
  • Otulfi (ustekinumab-aauz)
    BLA Number: 761379
    351(k) Interchangeable
  • Otulfi (ustekinumab-aauz)
    BLA Number: 761379
    351(k) Interchangeable
  • Otulfi (ustekinumab-aauz)
    BLA Number: 761379
    351(k) Interchangeable
  • Ovidrel (choriogonadotropin alfa)
    BLA Number: 021149
    351(a)
  • Ovidrel (choriogonadotropin alfa)
    BLA Number: 021149
    351(a)
  • Oxervate (cenegermin-bkbj)
    BLA Number: 761094
    351(a)
  • Oziltus (denosumab-mobz)
    BLA Number: 761457
    351(k) Interchangeable
  • Padcev (enfortumab vedotin-ejfv)
    BLA Number: 761137
    351(a)
  • Padcev (enfortumab vedotin-ejfv)
    BLA Number: 761137
    351(a)
  • Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
    BLA Number: 125696
    351(a)
  • Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
    BLA Number: 125696
    351(a)
  • Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
    BLA Number: 125696
    351(a)
  • Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
    BLA Number: 125696
    351(a)
  • Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
    BLA Number: 125696
    351(a)
  • Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
    BLA Number: 125696
    351(a)
  • Palynziq (pegvaliase-pqpz)
    BLA Number: 761079
    351(a)
  • Palynziq (pegvaliase-pqpz)
    BLA Number: 761079
    351(a)
  • Palynziq (pegvaliase-pqpz)
    BLA Number: 761079
    351(a)
  • Pancreaze (pancrelipase)
    BLA Number: 022523
    351(a)
  • Pancreaze (pancrelipase)
    BLA Number: 022523
    351(a)
  • Pancreaze (pancrelipase)
    BLA Number: 022523
    351(a)
  • Pancreaze (pancrelipase)
    BLA Number: 022523
    351(a)
  • Pancreaze (pancrelipase)
    BLA Number: 022523
    351(a)
  • Pancreaze (pancrelipase)
    BLA Number: 022523
    351(a)
  • Panhematin (Hemin for Injection)
    BLA Number: 101246
    351(a)
  • Panzyga (Immune Globulin Intravenous (Human)-ifas)
    BLA Number: 125587
    351(a)
  • Panzyga (Immune Globulin Intravenous (Human)-ifas)
    BLA Number: 125587
    351(a)
  • Panzyga (Immune Globulin Intravenous (Human)-ifas)
    BLA Number: 125587
    351(a)
  • Panzyga (Immune Globulin Intravenous (Human)-ifas)
    BLA Number: 125587
    351(a)
  • Panzyga (Immune Globulin Intravenous (Human)-ifas)
    BLA Number: 125587
    351(a)
  • Panzyga (Immune Globulin Intravenous (Human)-ifas)
    BLA Number: 125587
    351(a)
  • PAPZIMEOS (zopapogene imadenovec-drba)
    BLA Number: 125832
    351(a)
  • Pavblu (aflibercept-ayyh)
    BLA Number: 761298
    351(k) Biosimilar
  • Pavblu (aflibercept-ayyh)
    BLA Number: 761298
    351(k) Biosimilar
  • Pediarix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine)
    BLA Number: 103907
    351(a)
  • Pedvaxhib (Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate))
    BLA Number: 103237
    351(a)
  • Pegasys (peginterferon alfa-2a)
    BLA Number: 103964
    351(a)
  • Pegasys (peginterferon alfa-2a)
    BLA Number: 103964
    351(a)
  • Pegasys (peginterferon alfa-2a)
    BLA Number: 103964
    351(a)
  • Pegasys (peginterferon alfa-2a)
    BLA Number: 103964
    351(a)
  • Pegasys Copegus Combination Pack (peginterferon alfa-2a and ribavirin)
    BLA Number: 125083
    351(a)
  • Pegasys Copegus Combination Pack (peginterferon alfa-2a and ribavirin)
    BLA Number: 125083
    351(a)
  • Pegasys Copegus Combination Pack (peginterferon alfa-2a and ribavirin)
    BLA Number: 125083
    351(a)
  • Pegintron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • Pegintron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • Pegintron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • Pegintron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • Pegintron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • Pegintron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • Pegintron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • Pegintron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • PegIntron/ Rebetol Combo Pack (peginterferon alfa-2b and ribavirin)
    BLA Number: 125196
    351(a)
  • PegIntron/ Rebetol Combo Pack (peginterferon alfa-2b and ribavirin)
    BLA Number: 125196
    351(a)
  • PegIntron/ Rebetol Combo Pack (peginterferon alfa-2b and ribavirin)
    BLA Number: 125196
    351(a)
  • PegIntron/ Rebetol Combo Pack (peginterferon alfa-2b and ribavirin)
    BLA Number: 125196
    351(a)
  • PENBRAYA (Meningococcal Groups A, B, C, W, and Y Vaccine)
    BLA Number: 125770
    351(a)
  • PENMENVY (Meningococcal Groups A, B, C, W and Y Vaccine)
    BLA Number: 125819
    351(a)
  • Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine)
    BLA Number: 125145
    351(a)
  • Pergonal (menotropins)
    BLA Number: 017646
    351(a)
  • Pergonal (menotropins)
    BLA Number: 017646
    351(a)
  • Perjeta (pertuzumab)
    BLA Number: 125409
    351(a)
  • Pertzye (pancrelipase)
    BLA Number: 022175
    351(a)
  • Pertzye (pancrelipase)
    BLA Number: 022175
    351(a)
  • Pertzye (pancrelipase)
    BLA Number: 022175
    351(a)
  • Pertzye (pancrelipase)
    BLA Number: 022175
    351(a)
  • Pharmalgen (Venoms, Honey Bee Venom)
    BLA Number: 103969
    351(a)
  • Pharmalgen (Venoms, Honey Bee Venom)
    BLA Number: 103969
    351(a)
  • Pharmalgen (Venoms, Mixed Vespid Venom Protein)
    BLA Number: 103970
    351(a)
  • Pharmalgen (Venoms, Mixed Vespid Venom Protein)
    BLA Number: 103970
    351(a)
  • Pharmalgen (Venoms, Wasp Venom Protein)
    BLA Number: 103971
    351(a)
  • Pharmalgen (Venoms, Wasp Venom Protein)
    BLA Number: 103971
    351(a)
  • Pharmalgen (Venoms, White Faced Hornet Venom Protein)
    BLA Number: 103972
    351(a)
  • Pharmalgen (Venoms, White Faced Hornet Venom Protein)
    BLA Number: 103972
    351(a)
  • Pharmalgen (Venoms, Yellow Hornet Venom Protein)
    BLA Number: 103973
    351(a)
  • Pharmalgen (Venoms, Yellow Hornet Venom Protein)
    BLA Number: 103973
    351(a)
  • Pharmalgen (Venoms, Yellow Jacket Venom Protein)
    BLA Number: 103974
    351(a)
  • Pharmalgen (Venoms, Yellow Jacket Venom Protein)
    BLA Number: 103974
    351(a)
  • Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf)
    BLA Number: 761170
    351(a)
  • Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf)
    BLA Number: 761170
    351(a)
  • Piasky (crovalimab-akkz)
    BLA Number: 761388
    351(a)
  • Plasmanate (Plasma Protein Fraction (Human))
    BLA Number: 101140
    351(a)
  • Plasmanate (Plasma Protein Fraction (Human))
    BLA Number: 101140
    351(a)
  • Plasmanate (Plasma Protein Fraction (Human))
    BLA Number: 101140
    351(a)
  • Plegridy (peginterferon beta-1a)
    BLA Number: 125499
    351(a)
  • Plegridy (peginterferon beta-1a)
    BLA Number: 125499
    351(a)
  • Plegridy (peginterferon beta-1a)
    BLA Number: 125499
    351(a)
  • Plegridy (peginterferon beta-1a)
    BLA Number: 125499
    351(a)
  • Plegridy (peginterferon beta-1a)
    BLA Number: 125499
    351(a)
  • Plegridy (peginterferon beta-1a)
    BLA Number: 125499
    351(a)
  • Pneumovax 23 (Pneumococcal Vaccine, Polyvalent)
    BLA Number: 101094
    351(a)
  • Pneumovax 23 (Pneumococcal Vaccine, Polyvalent)
    BLA Number: 101094
    351(a)
  • Poherdy (pertuzumab-dpzb)
    BLA Number: 761450
    351(k) Interchangeable
  • Poliovax (Poliovirus Vaccine Inactivated (Human Diploid Cell))
    BLA Number: 103940
    351(a)
  • Poliovax (Poliovirus Vaccine Inactivated (Human Diploid Cell))
    BLA Number: 103940
    351(a)
  • Polivy (polatuzumab vedotin-piiq)
    BLA Number: 761121
    351(a)
  • Polivy (polatuzumab vedotin-piiq)
    BLA Number: 761121
    351(a)
  • Pombiliti (cipaglucosidase alfa-atga)
    BLA Number: 761204
    351(a)
  • Ponlimsi (denosumab-adet)
    BLA Number: 761385
    351(k) Interchangeable
  • Portrazza (necitumumab)
    BLA Number: 125547
    351(a)
  • Poteligeo (mogamulizumab-kpkc)
    BLA Number: 761051
    351(a)
  • Praluent (alirocumab)
    BLA Number: 125559
    351(a)
  • Praluent (alirocumab)
    BLA Number: 125559
    351(a)
  • Praluent (alirocumab)
    BLA Number: 125559
    351(a)
  • Praluent (alirocumab)
    BLA Number: 125559
    351(a)
  • Praxbind (idarucizumab)
    BLA Number: 761025
    351(a)
  • Pre-Pen (benzylpenicilloyl polylysine)
    BLA Number: 050114
    351(a)
  • Pregnyl (chorionic gonadotropin)
    BLA Number: 017692
    351(a)
  • Prehevbrio (Hepatitis B Vaccine (Recombinant))
    BLA Number: 125737
    351(a)
  • prevnar (Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein))
    BLA Number: 103905
    351(a)
  • Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein))
    BLA Number: 125324
    351(a)
  • Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine)
    BLA Number: 125731
    351(a)
  • PRIORIX (Measles, Mumps and Rubella Vaccine Live)
    BLA Number: 125748
    351(a)
  • Privigen (Immune Globulin Intravenous (Human), 10% Liquid)
    BLA Number: 125201
    351(a)
  • Privigen (Immune Globulin Intravenous (Human), 10% Liquid)
    BLA Number: 125201
    351(a)
  • Privigen (Immune Globulin Intravenous (Human), 10% Liquid)
    BLA Number: 125201
    351(a)
  • Privigen (Immune Globulin Intravenous (Human), 10% Liquid)
    BLA Number: 125201
    351(a)
  • Privigen (Immune Globulin Intravenous (Human), 10% Liquid)
    BLA Number: 125201
    351(a)
  • Procrit (epoetin alfa)
    BLA Number: 103234
    351(a)
  • Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd (Factor IX Complex)
    BLA Number: 102476
    351(a)
  • Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd (Factor IX Complex)
    BLA Number: 102476
    351(a)
  • Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd (Factor IX Complex)
    BLA Number: 102476
    351(a)
  • prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 103174
    351(a)
  • prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 103174
    351(a)
  • prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 103174
    351(a)
  • prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 103174
    351(a)
  • prolastin,prolastin-c,prolastin-c liquid (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 103174
    351(a)
  • Proleukin (aldesleukin)
    BLA Number: 103293
    351(a)
  • Prolia (denosumab)
    BLA Number: 125320
    351(a)
  • Prolia (denosumab)
    BLA Number: 125320
    351(a)
  • Proplex-T; Bebulin (Factor IX Complex)
    BLA Number: 103112
    351(a)
  • Proquad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)
    BLA Number: 125108
    351(a)
  • Proquad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live)
    BLA Number: 125108
    351(a)
  • ProstaScint (capromab pendetide)
    BLA Number: 103608
    351(a)
  • Provenge (sipuleucel-T)
    BLA Number: 125197
    351(a)
  • Pulmolite (kit for the preparation of technetium Tc-99m albumin aggregated)
    BLA Number: 017776
    351(a)
  • Pulmotech MAA (kit for the preparation of technetium Tc-99m albumin aggregated)
    BLA Number: 210089
    351(a)
  • Pulmozyme (dornase alfa)
    BLA Number: 103532
    351(a)
  • Pyzchiva (ustekinumab-ttwe)
    BLA Number: 761373
    351(k) Interchangeable
  • Pyzchiva (ustekinumab-ttwe)
    BLA Number: 761425
    351(k) Interchangeable
  • Pyzchiva (ustekinumab-ttwe)
    BLA Number: 761373
    351(k) Interchangeable
  • Pyzchiva (ustekinumab-ttwe)
    BLA Number: 761373
    351(k) Interchangeable
  • Pyzchiva (ustekinumab-ttwe)
    BLA Number: 761373
    351(k) Interchangeable
  • Pyzchiva (ustekinumab-ttwe)
    BLA Number: 761373
    351(k) Interchangeable
  • QIVIGY (Immune Globulin Intravenous, Human-kthm, 10% Solution)
    BLA Number: 125822
    351(a)
  • QIVIGY (Immune Globulin Intravenous, Human-kthm, 10% Solution)
    BLA Number: 125822
    351(a)
  • Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
    BLA Number: 125525
    351(a)
  • Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
    BLA Number: 125525
    351(a)
  • Qwo (collagenase clostridium histolyticum-aaes)
    BLA Number: 761146
    351(a)
  • Qwo (collagenase clostridium histolyticum-aaes)
    BLA Number: 761146
    351(a)
  • Rabavert (Rabies Vaccine)
    BLA Number: 103334
    351(a)
  • Ragwitek (Short Ragweed Pollen Allergen Extract)
    BLA Number: 125478
    351(a)
  • Raplixa (Fibrin Sealant (Human))
    BLA Number: 125523
    351(a)
  • Raplixa (Fibrin Sealant (Human))
    BLA Number: 125523
    351(a)
  • Raplixa (Fibrin Sealant (Human))
    BLA Number: 125523
    351(a)
  • Raptiva (efalizumab)
    BLA Number: 125075
    351(a)
  • Rebif (interferon beta-1a)
    BLA Number: 103780
    351(a)
  • Rebif (interferon beta-1a)
    BLA Number: 103780
    351(a)
  • Rebif (interferon beta-1a)
    BLA Number: 103780
    351(a)
  • Rebif (interferon beta-1a)
    BLA Number: 103780
    351(a)
  • Rebif (interferon beta-1a)
    BLA Number: 103780
    351(a)
  • Rebif (interferon beta-1a)
    BLA Number: 103780
    351(a)
  • Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated)
    BLA Number: 125611
    351(a)
  • Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated)
    BLA Number: 125611
    351(a)
  • Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated)
    BLA Number: 125611
    351(a)
  • Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated)
    BLA Number: 125611
    351(a)
  • Reblozyl (luspatercept-aamt)
    BLA Number: 761136
    351(a)
  • Reblozyl (luspatercept-aamt)
    BLA Number: 761136
    351(a)
  • Rebyota (fecal microbiota, live-jslm)
    BLA Number: 125739
    351(a)
  • Recombivax, Recombivax Hb (Hepatitis B Vaccine (Recombinant))
    BLA Number: 101066
    351(a)
  • Recombivax, Recombivax Hb (Hepatitis B Vaccine (Recombinant))
    BLA Number: 101066
    351(a)
  • Recombivax, Recombivax Hb (Hepatitis B Vaccine (Recombinant))
    BLA Number: 101066
    351(a)
  • Recothrom (Thrombin topical (Recombinant))
    BLA Number: 125248
    351(a)
  • Recothrom (Thrombin topical (Recombinant))
    BLA Number: 125248
    351(a)
  • Refacto (Antihemophilic Factor (Recombinant))
    BLA Number: 103779
    351(a)
  • Refacto (Antihemophilic Factor (Recombinant))
    BLA Number: 103779
    351(a)
  • Refacto (Antihemophilic Factor (Recombinant))
    BLA Number: 103779
    351(a)
  • Refacto (Antihemophilic Factor (Recombinant))
    BLA Number: 103779
    351(a)
  • regenecyte (HPC, Cord Blood)
    BLA Number: 125764
    351(a)
  • Regranex (becaplermin)
    BLA Number: 103691
    351(a)
  • Releuko (filgrastim-ayow)
    BLA Number: 761082
    351(k) Biosimilar
  • Releuko (filgrastim-ayow)
    BLA Number: 761082
    351(k) Biosimilar
  • Releuko (filgrastim-ayow)
    BLA Number: 761082
    351(k) Biosimilar
  • Releuko (filgrastim-ayow)
    BLA Number: 761082
    351(k) Biosimilar
  • Remicade (infliximab)
    BLA Number: 103772
    351(a)
  • Renflexis (infliximab-abda)
    BLA Number: 761054
    351(k) Biosimilar
  • Reopro (abciximab)
    BLA Number: 103575
    351(a)
  • Repatha (evolocumab)
    BLA Number: 125522
    351(a)
  • Repatha (evolocumab)
    BLA Number: 125522
    351(a)
  • Repatha (evolocumab)
    BLA Number: 125522
    351(a)
  • Repronex (menotropins)
    BLA Number: 021047
    351(a)
  • Repronex (menotropins)
    BLA Number: 021047
    351(a)
  • Retacrit (epoetin alfa-epbx)
    BLA Number: 125545
    351(k) Biosimilar
  • Retacrit (epoetin alfa-epbx)
    BLA Number: 125545
    351(k) Biosimilar
  • Retacrit (epoetin alfa-epbx)
    BLA Number: 125545
    351(k) Biosimilar
  • Retacrit (epoetin alfa-epbx)
    BLA Number: 125545
    351(k) Biosimilar
  • Retacrit (epoetin alfa-epbx)
    BLA Number: 125545
    351(k) Biosimilar
  • Retacrit (epoetin alfa-epbx)
    BLA Number: 125545
    351(k) Biosimilar
  • Retacrit (epoetin alfa-epbx)
    BLA Number: 125545
    351(k) Biosimilar
  • Retavase (reteplase)
    BLA Number: 103786
    351(a)
  • Rethymic (allogeneic processed thymus tissue-agdc)
    BLA Number: 125685
    351(a)
  • Revcovi (elapegademase-lvlr)
    BLA Number: 761092
    351(a)
  • Rezvoglar (insulin glargine-aglr)
    BLA Number: 761215
    351(k) Interchangeable
  • Rhophylac (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 125070
    351(a)
  • Rhophylac (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 125070
    351(a)
  • Riabni (rituximab-arrx)
    BLA Number: 761140
    351(k) Biosimilar
  • Riabni (rituximab-arrx)
    BLA Number: 761140
    351(k) Biosimilar
  • Riastap (Fibrinogen Concentrate (Human))
    BLA Number: 125317
    351(a)
  • Rituxan (rituximab)
    BLA Number: 103737
    351(a)
  • Rituxan (rituximab)
    BLA Number: 103737
    351(a)
  • Rituxan (rituximab)
    BLA Number: 103705
    351(a)
  • Rituxan (rituximab)
    BLA Number: 103705
    351(a)
  • Rituxan Hycela (rituximab and hyaluronidase human)
    BLA Number: 761064
    351(a)
  • Rituxan Hycela (rituximab and hyaluronidase human)
    BLA Number: 761064
    351(a)
  • Rixubis (Coagulation Factor IX (Recombinant))
    BLA Number: 125446
    351(a)
  • Rixubis (Coagulation Factor IX (Recombinant))
    BLA Number: 125446
    351(a)
  • Rixubis (Coagulation Factor IX (Recombinant))
    BLA Number: 125446
    351(a)
  • Rixubis (Coagulation Factor IX (Recombinant))
    BLA Number: 125446
    351(a)
  • Rixubis (Coagulation Factor IX (Recombinant))
    BLA Number: 125446
    351(a)
  • Roctavian (valoctocogene roxaparvovec-rvox)
    BLA Number: 125720
    351(a)
  • Roferon-A (interferon alfa-2a)
    BLA Number: 103145
    351(a)
  • Rolvedon (eflapegrastim-xnst)
    BLA Number: 761148
    351(a)
  • Rotarix (Rotavirus Vaccine, Live, Oral)
    BLA Number: 125265
    351(a)
  • Rotarix (Rotavirus Vaccine, Live, Oral)
    BLA Number: 125265
    351(a)
  • Rotarix (Rotavirus Vaccine, Live, Oral)
    BLA Number: 125265
    351(a)
  • Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent)
    BLA Number: 125122
    351(a)
  • Rotateq (Rotavirus Vaccine, Live, Oral, Pentavalent)
    BLA Number: 125122
    351(a)
  • Ruconest (C1 Esterase Inhibitor (Recombinant))
    BLA Number: 125495
    351(a)
  • Ruxience (rituximab-pvvr)
    BLA Number: 761103
    351(k) Biosimilar
  • Ruxience (rituximab-pvvr)
    BLA Number: 761103
    351(k) Biosimilar
  • Rybrevant (amivantamab-vmjw)
    BLA Number: 761210
    351(a)
  • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    BLA Number: 761484
    351(a)
  • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    BLA Number: 761484
    351(a)
  • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    BLA Number: 761484
    351(a)
  • Rybrevant Faspro (amivantamab and hyaluronidase-lpuj)
    BLA Number: 761484
    351(a)
  • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
    BLA Number: 761179
    351(a)
  • ryoncil (remestemcel-L-rknd)
    BLA Number: 125706
    351(a)
  • Ryplazim (plasminogen, human-tvmh)
    BLA Number: 125659
    351(a)
  • Rystiggo (rozanolixizumab-noli)
    BLA Number: 761286
    351(a)
  • Rystiggo (rozanolixizumab-noli)
    BLA Number: 761286
    351(a)
  • Rystiggo (rozanolixizumab-noli)
    BLA Number: 761286
    351(a)
  • Rystiggo (rozanolixizumab-noli)
    BLA Number: 761286
    351(a)
  • Ryzneuta (efbemalenograstim alfa-vuxw)
    BLA Number: 761134
    351(a)
  • Ryzodeg 70/30 (insulin degludec and insulin aspart)
    BLA Number: 203313
    351(a)
  • Saizen (somatropin)
    BLA Number: 019764
    351(a)
  • Saizen (somatropin)
    BLA Number: 019764
    351(a)
  • Saizen (somatropin)
    BLA Number: 019764
    351(a)
  • Saizen (somatropin)
    BLA Number: 019764
    351(a)
  • Santyl (collagenase)
    BLA Number: 101995
    351(a)
  • Saphnelo (anifrolumab-fnia)
    BLA Number: 761123
    351(a)
  • Saphnelo (anifrolumab-fnia)
    BLA Number: 761451
    351(a)
  • Saphnelo (anifrolumab-fnia)
    BLA Number: 761451
    351(a)
  • Sarclisa (isatuximab-irfc)
    BLA Number: 761113
    351(a)
  • Sarclisa (isatuximab-irfc)
    BLA Number: 761113
    351(a)
  • Selarsdi (ustekinumab-aekn)
    BLA Number: 761343
    351(k) Interchangeable
  • Selarsdi (ustekinumab-aekn)
    BLA Number: 761343
    351(k) Interchangeable
  • Selarsdi (ustekinumab-aekn)
    BLA Number: 761343
    351(k) Interchangeable
  • Selarsdi (ustekinumab-aekn)
    BLA Number: 761343
    351(k) Interchangeable
  • Semglee (insulin glargine)
    BLA Number: 210605
    351(a)
  • Semglee (insulin glargine)
    BLA Number: 210605
    351(a)
  • Semglee (insulin glargine-yfgn)
    BLA Number: 761201
    351(k) Interchangeable
  • Semglee (insulin glargine-yfgn)
    BLA Number: 761201
    351(k) Interchangeable
  • Serostim (somatropin)
    BLA Number: 020604
    351(a)
  • Serostim (somatropin)
    BLA Number: 020604
    351(a)
  • Serostim (somatropin)
    BLA Number: 020604
    351(a)
  • Serostim (somatropin)
    BLA Number: 020604
    351(a)
  • Sevenfact (coagulation factor VIIa (recombinant)-jncw)
    BLA Number: 125641
    351(a)
  • Sevenfact (coagulation factor VIIa (recombinant)-jncw)
    BLA Number: 125641
    351(a)
  • Sevenfact (coagulation factor VIIa (recombinant)-jncw)
    BLA Number: 125641
    351(a)
  • Shingrix (Zoster Vaccine Recombinant, Adjuvanted)
    BLA Number: 125614
    351(a)
  • Shingrix (Zoster Vaccine Recombinant, Adjuvanted)
    BLA Number: 125614
    351(a)
  • Shingrix (Zoster Vaccine Recombinant, Adjuvanted)
    BLA Number: 125614
    351(a)
  • Siliq (brodalumab)
    BLA Number: 761032
    351(a)
  • Simlandi (adalimumab-ryvk)
    BLA Number: 761299
    351(k) Interchangeable
  • Simlandi (adalimumab-ryvk)
    BLA Number: 761299
    351(k) Interchangeable
  • Simlandi (adalimumab-ryvk)
    BLA Number: 761299
    351(k) Interchangeable
  • Simlandi (adalimumab-ryvk)
    BLA Number: 761299
    351(k) Interchangeable
  • Simlandi (adalimumab-ryvk)
    BLA Number: 761299
    351(k) Interchangeable
  • Simponi (golimumab)
    BLA Number: 125289
    351(a)
  • Simponi (golimumab)
    BLA Number: 125289
    351(a)
  • Simponi (golimumab)
    BLA Number: 125289
    351(a)
  • Simponi (golimumab)
    BLA Number: 125289
    351(a)
  • Simponi Aria (golimumab)
    BLA Number: 125433
    351(a)
  • Simulect (basiliximab)
    BLA Number: 103764
    351(a)
  • Simulect (basiliximab)
    BLA Number: 103764
    351(a)
  • Skyrizi (risankizumab-rzaa)
    BLA Number: 761105
    351(a)
  • Skyrizi (risankizumab-rzaa)
    BLA Number: 761105
    351(a)
  • Skyrizi (risankizumab-rzaa)
    BLA Number: 761105
    351(a)
  • Skyrizi (risankizumab-rzaa)
    BLA Number: 761105
    351(a)
  • Skyrizi (risankizumab-rzaa)
    BLA Number: 761105
    351(a)
  • Skyrizi (risankizumab-rzaa)
    BLA Number: 761105
    351(a)
  • Skyrizi (risankizumab-rzaa)
    BLA Number: 761105
    351(a)
  • Skyrizi (risankizumab-rzaa)
    BLA Number: 761262
    351(a)
  • Skysona (elivaldogene autotemcel)
    BLA Number: 125755
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Skytrofa (lonapegsomatropin-tcgd)
    BLA Number: 761177
    351(a)
  • Sogroya (somapacitan-beco)
    BLA Number: 761156
    351(a)
  • Sogroya (somapacitan-beco)
    BLA Number: 761156
    351(a)
  • Sogroya (somapacitan-beco)
    BLA Number: 761156
    351(a)
  • Soliqua 100/33 (insulin glargine and lixisenatide)
    BLA Number: 208673
    351(a)
  • Soliris (eculizumab)
    BLA Number: 125166
    351(a)
  • Somavert (pegvisomant)
    BLA Number: 021106
    351(a)
  • Somavert (pegvisomant)
    BLA Number: 021106
    351(a)
  • Somavert (pegvisomant)
    BLA Number: 021106
    351(a)
  • Somavert (pegvisomant)
    BLA Number: 021106
    351(a)
  • Somavert (pegvisomant)
    BLA Number: 021106
    351(a)
  • Spevigo (spesolimab-sbzo)
    BLA Number: 761244
    351(a)
  • Spevigo (spesolimab-sbzo)
    BLA Number: 761244
    351(a)
  • Spevigo (spesolimab-sbzo)
    BLA Number: 761244
    351(a)
  • Spherusol (Coccidioides immitis Spherule-Derived Skin Test Antigen)
    BLA Number: 125354
    351(a)
  • Spikevax (COVID-19 Vaccine, mRNA)
    BLA Number: 125752
    351(a)
  • Spikevax (COVID-19 Vaccine, mRNA)
    BLA Number: 125752
    351(a)
  • Spikevax (COVID-19 Vaccine, mRNA)
    BLA Number: 125752
    351(a)
  • Spikevax (COVID-19 Vaccine, mRNA)
    BLA Number: 125752
    351(a)
  • Spikevax (COVID-19 Vaccine, mRNA)
    BLA Number: 125752
    351(a)
  • Starjemza (ustekinumab-hmny)
    BLA Number: 761419
    351(k) Interchangeable
  • Starjemza (ustekinumab-hmny)
    BLA Number: 761419
    351(k) Interchangeable
  • Starjemza (ustekinumab-hmny)
    BLA Number: 761419
    351(k) Interchangeable
  • Starjemza (ustekinumab-hmny)
    BLA Number: 761419
    351(k) Interchangeable
  • Stelara (ustekinumab)
    BLA Number: 125261
    351(a)
  • Stelara (ustekinumab)
    BLA Number: 125261
    351(a)
  • Stelara (ustekinumab)
    BLA Number: 125261
    351(a)
  • Stelara (ustekinumab)
    BLA Number: 125261
    351(a)
  • Stelara (ustekinumab)
    BLA Number: 761044
    351(a)
  • Steqeyma (ustekinumab-stba)
    BLA Number: 761338
    351(k) Interchangeable
  • Steqeyma (ustekinumab-stba)
    BLA Number: 761338
    351(k) Interchangeable
  • Steqeyma (ustekinumab-stba)
    BLA Number: 761338
    351(k) Interchangeable
  • Steqeyma (ustekinumab-stba)
    BLA Number: 761338
    351(k) Interchangeable
  • Stimufend (pegfilgrastim-fpgk)
    BLA Number: 761173
    351(k) Biosimilar
  • Stoboclo (denosumab-bmwo)
    BLA Number: 761404
    351(k) Interchangeable
  • StrataGraft (Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat)
    BLA Number: 125730
    351(a)
  • Strensiq (asfotase alfa)
    BLA Number: 125513
    351(a)
  • Strensiq (asfotase alfa)
    BLA Number: 125513
    351(a)
  • Strensiq (asfotase alfa)
    BLA Number: 125513
    351(a)
  • Strensiq (asfotase alfa)
    BLA Number: 125513
    351(a)
  • Sucraid (sacrosidase)
    BLA Number: 020772
    351(a)
  • Sucraid (sacrosidase)
    BLA Number: 020772
    351(a)
  • Survanta (beractant)
    BLA Number: 020032
    351(a)
  • Survanta (beractant)
    BLA Number: 020032
    351(a)
  • Susvimo (ranibizumab)
    BLA Number: 761197
    351(a)
  • Sylatron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • Sylatron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • Sylatron (peginterferon alfa-2b)
    BLA Number: 103949
    351(a)
  • Sylvant (siltuximab)
    BLA Number: 125496
    351(a)
  • Sylvant (siltuximab)
    BLA Number: 125496
    351(a)
  • symvess (acellular tissue engineered vessel-tyod)
    BLA Number: 125812
    351(a)
  • Synagis (palivizumab)
    BLA Number: 103770
    351(a)
  • Synagis (palivizumab)
    BLA Number: 103770
    351(a)
  • Synagis (palivizumab)
    BLA Number: 103770
    351(a)
  • Synagis (palivizumab)
    BLA Number: 103770
    351(a)
  • T.R.U.E. Test (Thin-Layer Rapid Use Epicutaneous Patch Test)
    BLA Number: 103738
    351(a)
  • Tachosil (Fibrin Sealant Patch)
    BLA Number: 125351
    351(a)
  • Tachosil (Fibrin Sealant Patch)
    BLA Number: 125351
    351(a)
  • Tachosil (Fibrin Sealant Patch)
    BLA Number: 125351
    351(a)
  • Takhzyro (lanadelumab-flyo)
    BLA Number: 761090
    351(a)
  • Takhzyro (lanadelumab-flyo)
    BLA Number: 761090
    351(a)
  • Takhzyro (lanadelumab-flyo)
    BLA Number: 761090
    351(a)
  • Taltz (ixekizumab)
    BLA Number: 125521
    351(a)
  • Taltz (ixekizumab)
    BLA Number: 125521
    351(a)
  • Taltz (ixekizumab)
    BLA Number: 125521
    351(a)
  • Taltz (ixekizumab)
    BLA Number: 125521
    351(a)
  • Talvey (talquetamab-tgvs)
    BLA Number: 761342
    351(a)
  • Talvey (talquetamab-tgvs)
    BLA Number: 761342
    351(a)
  • Tanzeum (albiglutide)
    BLA Number: 125431
    351(a)
  • Tanzeum (albiglutide)
    BLA Number: 125431
    351(a)
  • Tdvax (Tetanus and Diphtheria Toxoids Adsorbed)
    BLA Number: 101322
    351(a)
  • Tecartus (Brexucabtagene Autoleucel)
    BLA Number: 125703
    351(a)
  • tecelra (afamitresgene autoleucel)
    BLA Number: 125789
    351(a)
  • Tecentriq (atezolizumab)
    BLA Number: 761034
    351(a)
  • Tecentriq (atezolizumab)
    BLA Number: 761034
    351(a)
  • Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs)
    BLA Number: 761347
    351(a)
  • Tecvayli (teclistamab-cqyv)
    BLA Number: 761291
    351(a)
  • Tecvayli (teclistamab-cqyv)
    BLA Number: 761291
    351(a)
  • Tenivac (Tetanus and Diphtheria Toxoids Adsorbed)
    BLA Number: 103171
    351(a)
  • Tenivac (Tetanus and Diphtheria Toxoids Adsorbed)
    BLA Number: 103171
    351(a)
  • Tepezza (teprotumumab-trbw)
    BLA Number: 761143
    351(a)
  • Tevimbra (tislelizumab-jsgr)
    BLA Number: 761232
    351(a)
  • Tezspire (tezepelumab-ekko)
    BLA Number: 761224
    351(a)
  • Tezspire (tezepelumab-ekko)
    BLA Number: 761224
    351(a)
  • Tezspire (tezepelumab-ekko)
    BLA Number: 761224
    351(a)
  • TheraCys (BCG Live)
    BLA Number: 103943
    351(a)
  • Thrombate Iii (Antithrombin III (Human))
    BLA Number: 103196
    351(a)
  • Thrombin-Jmi, Thrombocoll (Thrombin, Topical (Bovine))
    BLA Number: 102865
    351(a)
  • Thrombin-Jmi, Thrombocoll (Thrombin, Topical (Bovine))
    BLA Number: 102865
    351(a)
  • Thrombin-Jmi, Thrombocoll (Thrombin, Topical (Bovine))
    BLA Number: 102865
    351(a)
  • Thrombin-Jmi, Thrombocoll (Thrombin, Topical (Bovine))
    BLA Number: 102865
    351(a)
  • Thymoglobulin (Anti-thymocyte Globulin (Rabbit))
    BLA Number: 103869
    351(a)
  • Thyrogen (thyrotropin alfa)
    BLA Number: 020898
    351(a)
  • Tice Bcg (BCG Live)
    BLA Number: 102821
    351(a)
  • Ticovac (Tick-Borne Encephalitis Vaccine)
    BLA Number: 125740
    351(a)
  • Ticovac (Tick-Borne Encephalitis Vaccine)
    BLA Number: 125740
    351(a)
  • Tisseel (Fibrin Sealant (Tisseel))
    BLA Number: 103980
    351(a)
  • Tisseel (Fibrin Sealant (Tisseel))
    BLA Number: 103980
    351(a)
  • Tivdak (tisotumab vedotin-tftv)
    BLA Number: 761208
    351(a)
  • TNKase (tenecteplase)
    BLA Number: 103909
    351(a)
  • TNKase (tenecteplase)
    BLA Number: 103909
    351(a)
  • Tofidence (tocilizumab-bavi)
    BLA Number: 761354
    351(k) Biosimilar
  • Tofidence (tocilizumab-bavi)
    BLA Number: 761354
    351(k) Biosimilar
  • Tofidence (tocilizumab-bavi)
    BLA Number: 761354
    351(k) Biosimilar
  • Toujeo (insulin glargine)
    BLA Number: 206538
    351(a)
  • Toujeo (insulin glargine)
    BLA Number: 206538
    351(a)
  • Trasylol (aprotinin)
    BLA Number: 020304
    351(a)
  • Trasylol (aprotinin)
    BLA Number: 020304
    351(a)
  • Trazimera (trastuzumab-qyyp)
    BLA Number: 761081
    351(k) Biosimilar
  • Trazimera (trastuzumab-qyyp)
    BLA Number: 761081
    351(k) Biosimilar
  • Tremfya (guselkumab)
    BLA Number: 761061
    351(a)
  • Tremfya (guselkumab)
    BLA Number: 761061
    351(a)
  • Tremfya (guselkumab)
    BLA Number: 761061
    351(a)
  • Tremfya (guselkumab)
    BLA Number: 761061
    351(a)
  • Tremfya (guselkumab)
    BLA Number: 761061
    351(a)
  • Tremfya (guselkumab)
    BLA Number: 761061
    351(a)
  • Tresiba (insulin degludec)
    BLA Number: 203314
    351(a)
  • Tresiba (insulin degludec)
    BLA Number: 203314
    351(a)
  • Tresiba (insulin degludec)
    BLA Number: 203314
    351(a)
  • Tretten (Coagulation Factor XIII A-Subunit (Recombinant))
    BLA Number: 125398
    351(a)
  • Tripedia (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed)
    BLA Number: 103922
    351(a)
  • Trodelvy (sacituzumab govitecan-hziy)
    BLA Number: 761115
    351(a)
  • Trogarzo (ibalizumab-uiyk)
    BLA Number: 761065
    351(a)
  • Trulicity (dulaglutide)
    BLA Number: 125469
    351(a)
  • Trulicity (dulaglutide)
    BLA Number: 125469
    351(a)
  • Trulicity (dulaglutide)
    BLA Number: 125469
    351(a)
  • Trulicity (dulaglutide)
    BLA Number: 125469
    351(a)
  • Trulicity (dulaglutide)
    BLA Number: 125469
    351(a)
  • Trulicity (dulaglutide)
    BLA Number: 125469
    351(a)
  • Trumenba (Meningococcal Group B Vaccine)
    BLA Number: 125549
    351(a)
  • Truxima (rituximab-abbs)
    BLA Number: 761088
    351(k) Biosimilar
  • Truxima (rituximab-abbs)
    BLA Number: 761088
    351(k) Biosimilar
  • Tubersol (Tuberculin, Purified Protein Derivative)
    BLA Number: 103941
    351(a)
  • Twinrix (Hepatitis A & Hepatitis B (Recombinant) Vaccine)
    BLA Number: 103850
    351(a)
  • Tyenne (tocilizumab-aazg)
    BLA Number: 761275
    351(k) Biosimilar
  • Tyenne (tocilizumab-aazg)
    BLA Number: 761449
    351(k) Biosimilar
  • Tyenne (tocilizumab-aazg)
    BLA Number: 761449
    351(k) Biosimilar
  • Tyenne (tocilizumab-aazg)
    BLA Number: 761275
    351(k) Biosimilar
  • Tyenne (tocilizumab-aazg)
    BLA Number: 761275
    351(k) Biosimilar
  • Typhim Vi (Typhoid Vi Polysaccharide Vaccine)
    BLA Number: 103936
    351(a)
  • Typhim Vi (Typhoid Vi Polysaccharide Vaccine)
    BLA Number: 103936
    351(a)
  • Tyruko (natalizumab-sztn)
    BLA Number: 761322
    351(k) Biosimilar
  • Tysabri (natalizumab)
    BLA Number: 125104
    351(a)
  • Tzield (teplizumab-mzwv)
    BLA Number: 761183
    351(a)
  • Udenyca (pegfilgrastim-cbqv)
    BLA Number: 761039
    351(k) Biosimilar
  • Udenyca (pegfilgrastim-cbqv)
    BLA Number: 761039
    351(k) Biosimilar
  • Udenyca Onbody (pegfilgrastim-cbqv)
    BLA Number: 761039
    351(k) Biosimilar
  • Ultomiris (ravulizumab-cwvz)
    BLA Number: 761108
    351(a)
  • Ultomiris (ravulizumab-cwvz)
    BLA Number: 761108
    351(a)
  • Ultomiris (ravulizumab-cwvz)
    BLA Number: 761108
    351(a)
  • Ultomiris (ravulizumab-cwvz)
    BLA Number: 761108
    351(a)
  • Unituxin (dinutuximab)
    BLA Number: 125516
    351(a)
  • Unloxcyt (cosibelimab-ipdl)
    BLA Number: 761297
    351(a)
  • Uplizna (inebilizumab-cdon)
    BLA Number: 761142
    351(a)
  • Vabysmo (faricimab-svoa)
    BLA Number: 761235
    351(a)
  • Vabysmo (faricimab-svoa)
    BLA Number: 761235
    351(a)
  • Vaqta (Hepatitis A Vaccine Inactivated)
    BLA Number: 103606
    351(a)
  • Vaqta (Hepatitis A Vaccine Inactivated)
    BLA Number: 103606
    351(a)
  • Vaqta (Hepatitis A Vaccine Inactivated)
    BLA Number: 103606
    351(a)
  • Vaqta (Hepatitis A Vaccine Inactivated)
    BLA Number: 103606
    351(a)
  • Varivax (Varicella Virus Vaccine Live)
    BLA Number: 103552
    351(a)
  • Varivax (Varicella Virus Vaccine Live)
    BLA Number: 103552
    351(a)
  • Varizig (Varicella Zoster Immune Globulin (Human))
    BLA Number: 125430
    351(a)
  • Varizig (Varicella Zoster Immune Globulin (Human))
    BLA Number: 125430
    351(a)
  • Vaxchora (Cholera Vaccine, Live, Oral)
    BLA Number: 125597
    351(a)
  • Vaxchora (Cholera Vaccine, Live, Oral)
    BLA Number: 125597
    351(a)
  • Vaxchora (Cholera Vaccine, Live, Oral)
    BLA Number: 125597
    351(a)
  • Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)
    BLA Number: 125563
    351(a)
  • Vaxelis (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)
    BLA Number: 125563
    351(a)
  • Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine)
    BLA Number: 125741
    351(a)
  • Vectibix (panitumumab)
    BLA Number: 125147
    351(a)
  • Vectibix (panitumumab)
    BLA Number: 125147
    351(a)
  • Vectibix (panitumumab)
    BLA Number: 125147
    351(a)
  • Vegzelma (bevacizumab-adcd)
    BLA Number: 761268
    351(k) Biosimilar
  • Vegzelma (bevacizumab-adcd)
    BLA Number: 761268
    351(k) Biosimilar
  • Veopoz (pozelimab-bbfg)
    BLA Number: 761339
    351(a)
  • Verluma (nofetumomab)
    BLA Number: 103769
    351(a)
  • Vimizim (elosulfase alfa)
    BLA Number: 125460
    351(a)
  • VIMKUNYA (Chikungunya Vaccine, Recombinant)
    BLA Number: 125820
    351(a)
  • Viokace (pancrelipase)
    BLA Number: 022542
    351(a)
  • Viokace (pancrelipase)
    BLA Number: 022542
    351(a)
  • Vistaseal (Fibrin Sealant (Human))
    BLA Number: 125640
    351(a)
  • Vistaseal (Fibrin Sealant (Human))
    BLA Number: 125640
    351(a)
  • Vistaseal (Fibrin Sealant (Human))
    BLA Number: 125640
    351(a)
  • Vistaseal (Fibrin Sealant (Human))
    BLA Number: 125640
    351(a)
  • Vitrase (hyaluronidase)
    BLA Number: 021640
    351(a)
  • Vitrase (hyaluronidase)
    BLA Number: 021640
    351(a)
  • Vivaglobin (Immune Globulin Subcutaneous (Human))
    BLA Number: 125115
    351(a)
  • Vivotif (Typhoid Vaccine Live Oral Ty21a)
    BLA Number: 103123
    351(a)
  • Vonvendi (von Willebrand factor (Recombinant))
    BLA Number: 125577
    351(a)
  • Vonvendi (von Willebrand factor (Recombinant))
    BLA Number: 125577
    351(a)
  • Voraxaze (glucarpidase)
    BLA Number: 125327
    351(a)
  • Vowst (fecal microbiota spores, live-brpk)
    BLA Number: 125757
    351(a)
  • Voyxact (sibeprenlimab-szsi)
    BLA Number: 761434
    351(a)
  • VPRIV (velaglucerase alfa)
    BLA Number: 022575
    351(a)
  • VPRIV (velaglucerase alfa)
    BLA Number: 022575
    351(a)
  • Vyepti (eptinezumab-jjmr)
    BLA Number: 761119
    351(a)
  • VYJUVEK (beremagene geperpavec-svdt)
    BLA Number: 125774
    351(a)
  • Vyloy (zolbetuximab-clzb)
    BLA Number: 761365
    351(a)
  • Vyloy (zolbetuximab-clzb)
    BLA Number: 761365
    351(a)
  • Vyvgart (efgartigimod alfa-fcab)
    BLA Number: 761195
    351(a)
  • Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
    BLA Number: 761304
    351(a)
  • Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
    BLA Number: 761304
    351(a)
  • waskyra (etuvetidigene autotemcel)
    BLA Number: 125846
    351(a)
  • Wezlana (ustekinumab-auub)
    BLA Number: 761285
    351(k) Interchangeable
  • Wezlana (ustekinumab-auub)
    BLA Number: 761285
    351(k) Biosimilar
  • Wezlana (ustekinumab-auub)
    BLA Number: 761285
    351(k) Biosimilar
  • Wezlana (ustekinumab-auub)
    BLA Number: 761285
    351(k) Interchangeable
  • Wezlana (ustekinumab-auub)
    BLA Number: 761331
    351(k) Interchangeable
  • Wezlana (ustekinumab-auub)
    BLA Number: 761285
    351(k) Interchangeable
  • Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human))
    BLA Number: 125251
    351(a)
  • Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human))
    BLA Number: 125251
    351(a)
  • Winrevair (sotatercept-csrk)
    BLA Number: 761363
    351(a)
  • Winrevair (sotatercept-csrk)
    BLA Number: 761363
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (Rho(D) Immune Globulin Intravenous (Human))
    BLA Number: 103649
    351(a)
  • Wyost (denosumab-bbdz)
    BLA Number: 761362
    351(k) Interchangeable
  • Xbryk (denosumab-dssb)
    BLA Number: 761392
    351(k) Interchangeable
  • Xembify (immune globulin subcutaneous, human-klhw)
    BLA Number: 125683
    351(a)
  • Xembify (immune globulin subcutaneous, human-klhw)
    BLA Number: 125683
    351(a)
  • Xembify (immune globulin subcutaneous, human-klhw)
    BLA Number: 125683
    351(a)
  • Xembify (immune globulin subcutaneous, human-klhw)
    BLA Number: 125683
    351(a)
  • Xenpozyme (olipudase alfa-rpcp)
    BLA Number: 761261
    351(a)
  • Xenpozyme (olipudase alfa-rpcp)
    BLA Number: 761261
    351(a)
  • Xeomin (incobotulinumtoxinA)
    BLA Number: 125360
    351(a)
  • Xeomin (incobotulinumtoxinA)
    BLA Number: 125360
    351(a)
  • Xeomin (incobotulinumtoxinA)
    BLA Number: 125360
    351(a)
  • Xgeva (denosumab)
    BLA Number: 125320
    351(a)
  • Xiaflex (collagenase clostridium histolyticum)
    BLA Number: 125338
    351(a)
  • Xigris (drotrecogin alfa)
    BLA Number: 125029
    351(a)
  • Xigris (drotrecogin alfa)
    BLA Number: 125029
    351(a)
  • Xolair (omalizumab)
    BLA Number: 103976
    351(a)
  • Xolair (omalizumab)
    BLA Number: 103976
    351(a)
  • Xolair (omalizumab)
    BLA Number: 103976
    351(a)
  • Xolair (omalizumab)
    BLA Number: 103976
    351(a)
  • Xolair (omalizumab)
    BLA Number: 103976
    351(a)
  • Xolair (omalizumab)
    BLA Number: 103976
    351(a)
  • Xolair (omalizumab)
    BLA Number: 103976
    351(a)
  • Xtrenbo (denosumab-qbde)
    BLA Number: 761439
    351(k) Interchangeable
  • Xultophy 100/3.6 (insulin degludec and liraglutide)
    BLA Number: 208583
    351(a)
  • Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
    BLA Number: 125264
    351(a)
  • Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
    BLA Number: 125264
    351(a)
  • Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
    BLA Number: 125264
    351(a)
  • Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
    BLA Number: 125264
    351(a)
  • Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
    BLA Number: 125264
    351(a)
  • Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
    BLA Number: 125264
    351(a)
  • Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
    BLA Number: 125264
    351(a)
  • Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
    BLA Number: 125264
    351(a)
  • Xyntha, Xyntha Solofuse (Antihemophilic Factor (Recombinant), Plasma/Albumin Free)
    BLA Number: 125264
    351(a)
  • Yartemlea (narsoplimab-wuug)
    BLA Number: 761152
    351(a)
  • Yervoy (ipilimumab)
    BLA Number: 125377
    351(a)
  • Yervoy (ipilimumab)
    BLA Number: 125377
    351(a)
  • Yesafili (aflibercept-jbvf)
    BLA Number: 761274
    351(k) Interchangeable
  • Yesafili (aflibercept-jbvf)
    BLA Number: 761274
    351(k) Biosimilar
  • Yescarta (axicabtagene ciloleucel)
    BLA Number: 125643
    351(a)
  • Yesintek (ustekinumab-kfce)
    BLA Number: 761406
    351(k) Interchangeable
  • Yesintek (ustekinumab-kfce)
    BLA Number: 761406
    351(k) Interchangeable
  • Yesintek (ustekinumab-kfce)
    BLA Number: 761406
    351(k) Interchangeable
  • Yesintek (ustekinumab-kfce)
    BLA Number: 761406
    351(k) Interchangeable
  • Yf-Vax (Yellow Fever Vaccine)
    BLA Number: 103915
    351(a)
  • Yf-Vax (Yellow Fever Vaccine)
    BLA Number: 103915
    351(a)
  • YIMMUGO (immune globulin intravenous, human-dira)
    BLA Number: 125810
    351(a)
  • YIMMUGO (immune globulin intravenous, human-dira)
    BLA Number: 125810
    351(a)
  • YIMMUGO (immune globulin intravenous, human-dira)
    BLA Number: 125810
    351(a)
  • Yuflyma (adalimumab-aaty)
    BLA Number: 761219
    351(k) Interchangeable
  • Yuflyma (adalimumab-aaty)
    BLA Number: 761219
    351(k) Interchangeable
  • Yuflyma (adalimumab-aaty)
    BLA Number: 761219
    351(k) Interchangeable
  • Yuflyma (adalimumab-aaty)
    BLA Number: 761219
    351(k) Interchangeable
  • Yuflyma (adalimumab-aaty)
    BLA Number: 761219
    351(k) Interchangeable
  • Yusimry (adalimumab-aqvh)
    BLA Number: 761216
    351(k) Biosimilar
  • Yusimry (adalimumab-aqvh)
    BLA Number: 761216
    351(k) Biosimilar
  • Zaltrap (Ziv-Aflibercept)
    BLA Number: 125418
    351(a)
  • Zaltrap (Ziv-Aflibercept)
    BLA Number: 125418
    351(a)
  • Zarxio (filgrastim-sndz)
    BLA Number: 125553
    351(k) Biosimilar
  • Zarxio (filgrastim-sndz)
    BLA Number: 125553
    351(k) Biosimilar
  • Zarxio (filgrastim-sndz)
    BLA Number: 125553
    351(k) Biosimilar
  • Zarxio (filgrastim-sndz)
    BLA Number: 125553
    351(k) Biosimilar
  • Zemaira (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 125078
    351(a)
  • Zemaira (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 125078
    351(a)
  • Zemaira (Alpha-1-Proteinase Inhibitor (Human))
    BLA Number: 125078
    351(a)
  • Zenapax (daclizumab)
    BLA Number: 103749
    351(a)
  • Zenpep (pancrelipase)
    BLA Number: 022210
    351(a)
  • Zenpep (pancrelipase)
    BLA Number: 022210
    351(a)
  • Zenpep (pancrelipase)
    BLA Number: 022210
    351(a)
  • Zenpep (pancrelipase)
    BLA Number: 022210
    351(a)
  • Zenpep (pancrelipase)
    BLA Number: 022210
    351(a)
  • Zenpep (pancrelipase)
    BLA Number: 022210
    351(a)
  • Zenpep (pancrelipase)
    BLA Number: 022210
    351(a)
  • Zenpep (pancrelipase)
    BLA Number: 022210
    351(a)
  • Zevalin (ibritumomab tiuxetan)
    BLA Number: 125019
    351(a)
  • zevaskyn (Prademagene zamikeracel)
    BLA Number: 125807
    351(a)
  • Ziextenzo (pegfilgrastim-bmez)
    BLA Number: 761045
    351(k) Biosimilar
  • Ziihera (zanidatamab-hrii)
    BLA Number: 761416
    351(a)
  • Zinbryta (daclizumab)
    BLA Number: 761029
    351(a)
  • Zinbryta (daclizumab)
    BLA Number: 761029
    351(a)
  • Zinplava (bezlotoxumab)
    BLA Number: 761046
    351(a)
  • Zirabev (bevacizumab-bvzr)
    BLA Number: 761099
    351(k) Biosimilar
  • Zirabev (bevacizumab-bvzr)
    BLA Number: 761099
    351(k) Biosimilar
  • Zolgensma (onasemnogene abeparvovec-xioi)
    BLA Number: 125694
    351(a)
  • Zomacton (somatropin)
    BLA Number: 019774
    351(a)
  • Zomacton (somatropin)
    BLA Number: 019774
    351(a)
  • Zomacton (somatropin)
    BLA Number: 019774
    351(a)
  • Zorbtive/Serostim (somatropin)
    BLA Number: 020604
    351(a)
  • Zostavax (Zoster Vaccine Live)
    BLA Number: 125123
    351(a)
  • Zymfentra (infliximab-dyyb)
    BLA Number: 761358
    351(a)
  • Zymfentra (infliximab-dyyb)
    BLA Number: 761358
    351(a)
  • Zynlonta (loncastuximab tesirine-lpyl)
    BLA Number: 761196
    351(a)
  • Zynteglo (betibeglogene autotemcel)
    BLA Number: 125717
    351(a)
  • Zynyz (retifanlimab-dlwr)
    BLA Number: 761334
    351(a)

Advanced Search

Database last updated: June 11, 2026

Glossary


Example: "Biosimilar"

3


351(a)
351(k) Biosimilar
351(k) Interchangeable

A


Applicant (sponsor)
Approval Date

B


Biological Product
Biosimilar
BLA
BLA Number

C


Center
Core Name

D


Date of First Licensure
Disc.
Disc.*
Dosage Form

E


Exclusivity Expiration Date

F


First Interchangeable Exclusivity Expiration Date

I


Interchangeable

L


License Number
License Type
Licensure

O


Orphan Exclusivity Expiration Date
OTC (Over-the-Counter)

P


Patent List Provided
Product Number
Proper Name
Proprietary Name
Purple Book

R


Reference Product
Reference Product Exclusivity Expiration Date
Route of Administration
Rx

M


Marketing Status

S


Strength
Submission Type
Supplement Number